Subglottic Secretion Drainage and Objective Outcomes a Systematic Review and Meta-analysis
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Rapid-flow expulsion maneuver in subglottic secretion clearance to prevent ventilator-associated pneumonia: a randomized controlled report
Annals of Intensive Care book 11, Commodity number:98 (2021) Cite this commodity
Abstract
Groundwork
Post-obit endotracheal intubation, clearing secretions above the endotracheal tube cuff decreases the incidence of ventilator-associated pneumonia (VAP); therefore, subglottic secretion drainage (SSD) is widely advocated. Our group adult a novel technique to remove the subglottic secretions, the rapid-menses expulsion maneuver (RFEM). The objective of this written report was to explore the effectiveness and condom of RFEM compared with SSD.
Methods
This written report was a unmarried-center, prospective, randomized and controlled trial, conducted at Respiratory Intensive Care Unit of measurement (ICU) of Beijing Chao-Yang Infirmary, a academy-affiliated 3rd hospital. The primary event was the incidence of VAP, assessed for not-inferiority.
Results
Patients with an endotracheal tube allowing drainage of subglottic secretions (due north = 241) were randomly assigned to either the RFEM group (n = 120) or SSD group (due north = 121). Eleven patients (9.17%) in the RFEM group and xiii (10.74%) in the SSD group developed VAP (difference, − 1.59; 95% confidence interval [CI] [− 9.20 half dozen.03]), equally the upper limit of 95% CI was not greater than the pre-defined non-inferiority limit (10%), RFEM was declared non-inferior to SSD. There were no statistically pregnant differences in the duration of mechanical ventilation, ICU mortality, or ICU length of stay and costs betwixt groups. In terms of safe, no accidental extubation or maneuver-related barotrauma occurred in the RFEM group. The incidence of postal service-extubation laryngeal edema and reintubation was similar in both groups.
Conclusions
RFEM is effective and safe, with non-inferiority compared to SSD in terms of the incidence of VAP. RFEM could be an alternative method in first-line treatment of respiratory ICU patients.
Trial registration This study has been registered on ClinicalTrials.gov (Registration Number: NCT02032849, https://clinicaltrials.gov/ct2/show/NCT02032849); registered on January 2014
Background
Establishment of an artificial airway is an important treatment approach in critically ill patients, which is commonly complicated past ventilator-associated pneumonia (VAP). Duration of mechanical ventilation, length and cost of time in intensive care unit (ICU), antibody treatment and patient mortality are significantly increased by VAP [i, 2]. The main crusade of VAP is the accumulation of secretions in the gap betwixt the glottis and the cuff afterward intubation, which cannot exist cleared by coughing. This leads to the spread of pathogens in the lower respiratory tract [three].
Several studies have confirmed the effectiveness of subglottic secretion drainage (SSD) in reducing the incidence of VAP [4, 5]. The use of an endotracheal tube with a subglottic suctioning lumen has been recommended past several VAP prevention guidelines in several countries including the U.s.a., Canada, and Communist china [six,7,8]. Even so, at that place are still some limitations to this procedure. For example, expensive specialized tubes are required, and the process is ofttimes accompanied past complications, such as airway mucosal injury, and poor drainage [ix, x].
Our team has developed an innovative technique to remove subglottic secretions, named the rapid-flow expulsion maneuver (RFEM). It uses a manual resuscitator to generate rapid-period expulsion which can articulate the subglottic secretions efficiently. It has been evaluated in in vitro and in vivo pre-trial investigations [11] and is patented and applied widely in more 50 ICUs in China since the 1990s. RFEM has been shown to be rubber, and price-effective [12, 13]. Still, there was still a lack of evidence from big-calibration randomized controlled trials (RCT) on the effectiveness of RFEM in preventing VAP. The technique RFEM has not been more than widely evaluated or used in other countries around the earth.
To obtain further evidence-based back up for the wider employ of RFEM, we performed this trial to explore the efficacy and safety of RFEM in preventing VAP compared with standard SSD.
Methods
Subjects
Patients intubated for less than 24 h in the respiratory ICU and aged eighteen years or older were eligible for this trial if they had an estimated survival time > two weeks. Patients were excluded if they had: ventilation parameters with positive end-expiratory pressure level (PEEP) > 10 cmHtwoO or fraction of inspired oxygen (FiO2) > 0.8; hemodynamic instability; history of astringent pulmonary bullae with pneumothorax; positive cuff leak test, which means patients with upper airway obstruction, it is difficult to button the secretion upwards to the oropharynx [14, 15] or had been included in other clinical studies. During the study, patients that were withdrawn from mechanical ventilation subsequently less than 72 h, or those whom refused treatment were as well excluded.
Trial pattern and randomization
This was a prospective, single-center, randomized, clinical control trial conducted in the Respiratory ICU at Beijing Chao-Yang Hospital, Capital Medical University (ClinicalTrials.gov, NCT02032849). This written report was approved past the Ethics Committee of Beijing Chao-Yang Hospital (2014-KE-106) and informed consent was obtained from the patients or their surrogates.
Randomization was performed using random numbers generated by the random number generator in the SPSS 23.0 statistical software (IBM Corp., Armonk, NY, USA). The enrolled patients (n = 241) were randomly assigned to either the RFEM group (due north = 120) or the SSD group (northward = 121). Allocation concealment was conducted using sequentially numbered opaque sealed envelopes. This was an unblinded trial because the physicians were aware of the treatment assigned to every participant. However, during the entire study period, the endpoint judgement and the statisticians were blinded.
Procedures
All patients enrolled in this report underwent endotracheal intubation along with a subglottic suctioning catheter (TaperGuard™ Evac Oral Tracheal Tube; Medtronic, USA). Clearance of subglottic secretions was performed every 6 h, and the secretion amounts were recorded.
Rapid-flow expulsion maneuver (RFEM)
A transmission resuscitator was attached to endotracheal tube and the gage deflated during the initiation of exhalation, the rapid menstruum produced by the manual resuscitator passing the space effectually the deflated cuff was used to remove subglottic secretions to the oropharynx. The operational procedure is completed by 2 operators (respiratory therapists or ICU nurses), described in Boosted file 1: S1, and Boosted file ii: Video S1 showed how RFEM works.
Subglottic secretion drainage (SSD)
A pressure of − 100 mmHg with a 15-southward duration was practical through a subglottic secretion drainage catheter connected to the sputum collector to advisedly suction oral and tracheal secretions while subjects were placed in a semi-recumbent position [11]. If the catheter became blocked, 5 ml of normal saline was instilled through the drainage lumen to maintain its patency [16].
Data collection, quality command and VAP prevention-package
After informed consent was obtained from the written report patients or surrogates, baseline data were recorded: historic period, sex, Acute Physiology and Chronic Health Evaluation (APACHE) 2 score, Sequential Organ Failure Assessment (SOFA) score at ICU admission, comorbidities, causes of tracheal intubation and laboratory examinations. Ventilator parameters were also recorded at randomization.
Daily information for a VAP-monitoring form were recorded for each enrolled patient and checked by 5 respiratory therapists. The diagnosis of VAP was initially fabricated according to the VAP diagnostic criteria (Boosted file 1: S2) by two blindly assigned ICU physicians. If the results were inconsistent, a microbiologist would participate to establish the diagnosis. Clinical data were recorded on paper case tape forms then double-entered into an electronic database and validated by the trial staff.
Other measures were taken to preclude VAP in the 2 groups, including raising the head of the bed, oral care using chlorhexidine, rational use of sedative and analgesic drugs, maintenance of cuff pressure inside 25–xxx cmH2O, replacement of ventilator tubes but when visible stains or failure occurred, early on limb rehabilitation exercise, and daily evaluation of extubation.
Endpoints
The incidence of VAP was the primary endpoint of the study. Patients enrolled in the study were followed-up prospectively for the occurrence of VAP until they received a tracheotomy, were successfully weaned from mechanical ventilation, discharged from the hospital, or died. The per protocol population contains patients who had PEEP below x cmH2O or FiO2 beneath 0.viii at report randomization. These patients were included in the intention-to-treat analysis.
The secondary endpoints included, mechanical ventilation elapsing, time from intubation to VAP, length of and cost of ICU stay, and mortality while in ICU. The daily book of subglottic secretions cleared and the need for tracheotomy and reintubation were also recorded.
The prophylactic of RFEM was assessed by recording episodes of pneumothorax, unplanned extubation and changes in vital signs during the maneuver process. Incidence of the post-extubation laryngeal dyspnea in both groups was as well evaluated equally a condom factor.
Statistical methods
Sample size calculation
The primary endpoint was evaluated using a non-inferiority analysis. Sample sizes of 120 participants per group achieve 80% power to detect a non-inferiority margin difference between the group proportions of 0.10, with a one-sided test significance level of 0.05, and a loss to follow-upward charge per unit of x%. Based on the incidence rates of VAP in patients requiring mechanical ventilation in our ICU prior to this report and the results of previous studies [17,xviii,19], the SSD group proportion is xv%, and the RFEM grouping proportion is xvi.vii%.
SPSS 23.0 software (IBM Corp., Armonk, NY, Us) was used for statistical assay. The level of significance for all statistical tests was 0.05 (ii-tailed). The measurement data were presented every bit means ± SD (standard deviations) or medians and quartile distribution (skewed distribution). Differences betwixt groups were analyzed using the assay of variance or nonparametric test (skewed distribution). Count information were presented as frequencies and percentages, and differences betwixt groups were tested using the χ two test or Fisher's exact exam. VAP-free survival curves in the two groups were displayed graphically according to the Kaplan–Meier method and analyzed using the log-rank test. Univariate and multivariate logistic regression was used to analyze the chance factors for the prevalence of VAP.
Results
Patient characteristics
Figure 1 shows the flowchart of patients admitted to the respiratory intensive care unit of measurement (RICU) betwixt Jan 2014 and December 2018. 1069 adult patients with mechanical ventilation were admitted, 806 of whom were excluded co-ordinate to the selection criteria. Finally, 120 patients were included in the RFEM group and 121 patients were included in the SSD group.
Flowchart of patients admitted to the respiratory intensive care unit (RICU) between January 2014 and December 2018
There were no statistically significant differences betwixt the two groups on study entry in a variety of factors including demographic information, comorbidities, Apache II or SOFA scores, hemodynamic status and laboratory examinations (Table 1, Additional file ane: Table S1). Table ane lists the causes of tracheal intubation. The main crusade for the ii groups was respiratory failure (69.17% of the RFEM group and 75.21% of the SSD grouping) with no pregnant difference between the groups. The main causes of respiratory failure were pneumonia and exacerbation of chronic obstructive pulmonary disease (Boosted file 1: Table S2). There were no statistically pregnant differences in arterial blood gas analysis, respiratory system compliance, or ventilator parameters, including PEEP, tidal volume, and plateau pressure at the fourth dimension of enrollment (Table 2).
Boosted file ane: Table S3 compares the chance factors for the development of VAP in both groups. In that location were no significant differences between the two groups in predisposing weather.
Chief endpoint
In the assay of the intention-to-care for population, the primary composite endpoint occurred in eleven (9.17%) patients in the RFEM grouping and in 13 (10.74%) patients in the SSD grouping, with an absolute run a risk deviation of − i.59% and a one-sided upper 95% confidence limit of 6.03% (p = 0.683 for non-inferiority, Table iii). The cumulative rates of patients remaining VAP-free in the two groups using the Kaplan–Meier curve showed that the charge per unit of VAP-free patients in the RFEM group was numerically college than that of the SSD group but without a statistically pregnant difference (log rank test, p = 0.364) (Fig. 2).
Kaplan–Meier curves of cumulative rates of patients remaining free of ventilator-associated pneumonia in two groups
Secondary endpoints
The fourth dimension from endotracheal intubation to a VAP diagnosis was also similar between the two groups (7.25 ± 7.94 days, 7.92 ± 3.77 days, respectively p = 0.793). There was no pregnant difference in the duration of mechanical ventilation, ICU mortality, the length of ICU stay, or ICU toll between the two groups. ICU mortality was xxx.00% in the RFEM grouping and 38.02% in the SSD group (p = 0.188) (Tabular array iii).
The multivariate logistic regression analysis of gamble factors associated with VAP showed that merely duration of mechanical ventilation significantly increased the risk of VAP (OR = i.047, 95%CI ane.008–i.087, p = 0.019). Ventilation duration was 13.iii ± seven.five days in patients developing VAP and eight.9 ± 7.8 days in the others (p = 0.010).
Reintubation was required in 12 (x.00%) patients in the RFEM group and 11 (ix.09%) patients in the SSD group without apparent clinical consequences. In that location was no significant difference in the incidence of pneumothorax, mediastinal emphysema, or subcutaneous emphysema between the two groups (Tabular array 3).
SSD was performed at a median of 24 times (16–48 times) per patient and RFEM 32 times (20–48 times) per patient. The median daily volume of subglottic secretions cleared was 9.67 ml (6.78–13.18 ml) in the RFEM group, significantly college than that of the SSD group (6.00 ml, 2.10–10.76 ml), p < 0.001.
Diagnosis of VAP-associated microorganisms
In that location was also no significant difference in the etiological distribution between the two groups (Additional file 1: Tabular array S4). Most of the pathogens responsible for VAP in the two groups were Gram-negative bacilli with the exception of Streptococcus constellatus in one patient of the RFEM group. Acinetobacter baumannii and Pseudomonas aeruginosa were the most commonly detected pathogens.
Safety
In terms of safety, no accidental extubation or maneuver-related barotrauma occurred in the RFEM group. Changes in vital signs during the process of RFEM were recorded (Additional file 1: Tabular array S5). The middle rate, claret force per unit area and respiratory charge per unit were significantly increased during the maneuver process of RFEM. However, during the report, there were only 0.36% (14/3860) episodes of a delayed RFEM owing to abnormal vital signs. Mail-extubation laryngeal edema occurred in 7 (5.83%) patients in the RFEM grouping and iv (three.31%) in the SSD group (p = 0.347).
Discussion
To the best of our knowledge, this is the first RCT to investigate the efficacy and condom of RFEM in preventing VAP compared with SSD. The major finding of our study is that there was no meaning divergence in the incidence of VAP betwixt the two groups. RFEM can avert the limitations of SSD, and we take verified RFEM to be a safe process without astringent complications.
Several RCTs and meta-analyses show that SSD tin can significantly reduce the incidence of VAP [4, 5, xviii,nineteen,20,21,22,23]. In this study, the incidence of VAP in the SSD group was ten.83%, which was consistent with previous studies [19, 20]. Jason Powell's written report showed that, especially in critically ill patients, intubation and mechanical ventilation tin can crusade an inflammatory subglottic surround where mucin hyper-secretion and enhanced viscosity is connected with neutrophil infiltration, damage of neutrophil part, neutrophil elastase release, and enriched VAP-causing pathogens [3]. Enhancement of subglottic mucus removal and/or disruption could be considered a logical target for improved VAP prevention [3]. Other measures have been taken to prevent VAP, including elevating the head of the bed, daily oral hygiene, reducing the utilise of sedatives and strengthening gage management [24,25,26,27]. The lower incidence of VAP in the SSD group in our results (10.8%) compared with the predicted incidence of VAP in the sample size calculation (thirty%) may be due to strict VAP bundles implementation and the fact that the diagnostic criteria for VAP remains a matter of debate [nineteen]. Our report applied a particularly stringent diagnostic criterion which required specific microbiological vigilance (Boosted file 1: Appendix S2).
Multiple studies accept found that half of patients accept a conventional tracheal tube established prior to ICU admission [19, 28,29,30], which limits the application of SSD. Furthermore, the price of the SSD tube is higher than a conventional tracheal tube. However, some studies have shown that the SSD method is more cost-effective for patients who are on mechanical ventilation > 48 h [31]; but the expected duration of intubation cannot be predicted at the offset of treatment. In regards to the SSD lumen, the larger outer diameter of the catheter increases the run a risk of laryngeal injury [22]. Additionally, SSD may cause impairment to the tracheal mucosa owing to the focus of negative pressure level on the small amount of oropharyngeal secretion gathered above the balloon [nine, x, 32]. An in vitro report indicated that the SSD drainage effect is significantly reduced when the secretion higher up the cuff balloon was less than 4 ml [33]. Furthermore, the thinner diameter of the drainage tube tin result in blockage by thick secretions.
Patients randomized to RFEM had a statistically similar incidence of VAP as patients in the SSD group. Nonetheless, the RFEM does not crave the SSD catheter or other special equipment and is not affected past the quantity and viscosity of the subglottic secretions. Therefore, the amount of daily subglottic secretions removed was greater in the RFEM group. In our study, we institute patient heart rate, claret pressure level and respiratory rate were significantly increased during the RFEM process. The procedure of sputum suction could partly explain these increases, as most patients returned to normal after a few minutes. No unplanned extubation or maneuver-related barotrauma occurred, and all conscious patients tolerated the procedure.
The technique RFEM applied widely in more 50 ICUs in Cathay, notwithstanding, has not been more widely evaluated or used in other countries around the world nor it has been discussed as a potential strategy to forestall VAP in the different international recommendations or guidelines (due to the lack of evidence certainly). This report is the first randomized controlled study to investigate the efficacy and safety of RFEM in preventing VAP compared with SSD. Due to participation of a single center with relatively small sample size, the effectiveness and safety of RFEM appears promising, but there are far too little information at present to exist able to make a argument with high confidence. We have besides started to conduct follow-up research and endeavor to cooperate with other centers in an attempt to include a larger sample size for verification and promotion.
The RFEM should exist an alternative method for hospitals where the SSD catheter has not still been popularized or for patients without the availability of subglottic suctioning catheters. Information technology is worth noting, withal, that RFEM has limitations under certain conditions. For patients requiring high PEEP support (e.g., PEEP > x cm HiiO), the rapid-menses expulsion might crusade the loss of PEEP and the collapse of alveoli when disconnecting patients from the ventilator. Furthermore, information technology is hard to push the secretion upwardly to the oropharynx in patients with an upper airway obstruction [14]. Otherwise, patients are supposed to lie in the supine position equally much as possible to guarantee the most effective drainage [11]. Additionally, the cooperation of two trained medical staff is required at each time, these features limit the dissemination and appropriation of the technique by the ICU healthcare workers worldwide.
In that location are several limitations to our study. First, it was a unmarried-center written report with relatively small-scale sample size, which was lacking a control group who received neither RFEM nor SSD, and the main cause of admission was respiratory infection. The small number of patients make it hard to exist confident of the relative safety of RFEM vs SSD. Large multi-center RCTs should be conducted to validate these findings and confirm the cost-effectiveness of RFEM. Second, the ICU expenses calculated in our report did not include the cost of human resource management. Lastly, the two operating procedures, RFEM and SSD, were visually distinguishable, thus the study could non be blinded to physicians and nurses. However, patients were randomized with similar baseline characteristics, and microbiologists blinded to the randomization used strict quantitative microbiological criteria to confirm VAP.
Conclusions
For the clearance of subglottic secretions and prevention of VAP, RFEM has a non-inferior efficacy and safety to SSD, and therefore, may serve as an alternative method for SSD. Given the size and center limitations of the study, it would suggest much more than cautious language regarding the condom and effectiveness of RFEM. It appears promising, simply there are far too little data now to exist able to claim this with confidence. Big multi-centre RCTs should be conducted to validate these findings and ostend the cost-effectiveness of RFEM.
Availability of information and materials
The authors confirm that all data generated or analyzed during this study are included in this published article and its additional information files.
Abbreviations
- APACHE II:
-
Acute Physiology and Chronic Health Evaluation II
- ICU:
-
Intensive care unit of measurement
- PEEP:
-
Positive terminate-expiratory force per unit area
- RCT:
-
Randomized controlled trials
- RFEM:
-
Rapid-flow expulsion maneuver
- SOFA:
-
Sequential Organ Failure Cess
- SSD:
-
Subglottic secretion drainage
- VAP:
-
Ventilator-associated pneumonia
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Acknowledgements
Non applicative.
Funding
This work was supported by Beijing Key Clinical Specialty Excellence Program of 2018 and Beijing Health and Science Applied science Achievements and Promotion Plan (2018-TG-08).
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YL and XY performed the statistical analysis and drafted the manuscript. BS generated the idea and concept for the written report, contributed to the information assay and data estimation, revised the manuscript, and took responsibility for the integrity of the information. XY, HCL, HWC, LW and YZ recorded and checked data, and performed the SSD and RFEM procedure. RW, XT, CW, ZHT and XYL contributed substantially to the study blueprint, information assay and estimation, and the writing of the manuscript. All authors read and approved the final manuscript.
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This study was canonical by the Ethics Committee of Beijing Chao-Yang Infirmary and informed consent was obtained from the patients or their surrogates.
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Consent for publication was obtained from all participants.
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No authors take potential conflicts to disembalm.
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Supplementary Data
Additional file 2: Video S1. Rapid-period expulsion maneuver.
Additional file i: Appendix S1.
The standard operating procedure for the rapid-flow expulsion maneuver (RFEM). Appendix S2. The definition of VAP and VAP prevention-bundle. Table S1. Hemodynamic status and Laboratory examinations of study patients at randomization. Table S2. Tracheal intubation due to respiratory failure. Table S3. Risk factors for VAP during the study period. Table S4. Microorganisms diagnosis of VAP in patients. Tabular array S5. Changes of vital signs during process of rapid-catamenia expulsion maneuver.
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Li, Y., Yuan, X., Sun, B. et al. Rapid-menstruation expulsion maneuver in subglottic secretion clearance to foreclose ventilator-associated pneumonia: a randomized controlled study. Ann. Intensive Care 11, 98 (2021). https://doi.org/10.1186/s13613-021-00887-five
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DOI : https://doi.org/10.1186/s13613-021-00887-5
Keywords
- Rapid-menses expulsion maneuver
- Subglottic secretion drainage
- Ventilator-associated pneumonia
Source: https://annalsofintensivecare.springeropen.com/articles/10.1186/s13613-021-00887-5
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