CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study

Abstract

BackgroundTo determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS).MethodsThis was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions.Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually.ResultsNo difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01) and a trend to a greater volume of aspirated SS secretions: (192.0[64–413] ml vs. 150[50–200], p = 0.19 (total)); (57.8[20–88.7] ml vs. 50[18.7–62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0–2] vs. 0 [0–3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65).Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03).No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality.ConclusionsThe use AG 100 system and AG tube in critically ill intubated patients is safe and effective in Pcuff control and SS drainage. Its protective role against VAP needs to be confirmed in a larger randomized trial.Trial registrationClinicalTrials.gov NCT01550978. Date of registration: February 21, 2012.

The Use of a Novel Endotracheal Tube and Airway Management System to Prevent Complications in Lung Transplantation

“…The AnapnoGuard™ AG100s system consists of a single lumen ETT (see Figure 1), a connection kit, and a control unit (see Figure 2). The ETT is a polyvinylchloride ellipsoidal tube with a thin wall polyurethane cuff, two suction lines, and an extra CO 2 venting line [5]. The ETT is connected to the AG100s control unit, which provides continuous cuff pressure regulation, irrigation, and suctioning via programmable cycles [5].…”

“…The ETT is a polyvinylchloride ellipsoidal tube with a thin wall polyurethane cuff, two suction lines, and an extra CO 2 venting line [5]. The ETT is connected to the AG100s control unit, which provides continuous cuff pressure regulation, irrigation, and suctioning via programmable cycles [5]. The device operates automatically within these cycles, where air samples from the subglottic space are taken to measure CO 2 levels and determine whether or not the cuff is sealing the trachea.…”

“…The system provides continuous monitoring of leaks around the cuff based on the carbon dioxide (CO 2 ) level in the subglottic space. At the same time, the system automatically performs programmable subglottic suction of secretions via synchronized, simultaneous rinsing with saline and suction [5]. The authors present a lung transplantation case that was placed on the AnapnoGuard™ AG100s system in the postoperative period with no complications.…”

The Effect of Endotracheal Tube Cuff Pressure Control on the Development of Microaspiration and Ventilator- Associated Pneumonia: Systematic Review

“…Bir çalışmada mikroaspirasyon görülme oranını azalttığı ancak gruplar arasında fark olmadığı belirlenirken ölçülen pepsin konsantrasyonları arasında anlamı fark bulundu (28). Bir çalışmada ise gruplar arasında mikroaspirasyon gelişimi açısından fark anlamlı bulundu (22 (25,27), diğer üç çalışmada istatistiksel olarak anlamlı fark bulundu (22,24,26). De Pascale ve ark.…”

Non-Pharmacological Interventions to Prevent Ventilator-Associated Pneumonia: A Literature Review

“…78 In two recent randomized feasibility trials, the CO 2 -based system prevented under-and overinflation without significant adverse events. 79,80 Whether the use of a CO 2 -based cuff monitor results in VAP prevention remains to be elucidated.…”