Evaluating Air Leak Detection in Intubated Patients

Not Applicable

Completed

• Conditions: Critical Care

• Registration Number: NCT01857986
• Lead Sponsor: Hospitech Respiration

Brief Summary

This trial is designed to assess the effectiveness of the AnapnoGaurd 100 system relative to standard of care (SOC) Control, in the course of mechanical ventilation and intubation. The main effectiveness aspect of this trial is the AnapnoGaurd 100's ability to reduce leaks between the endotracheal tube and the trachea walls as a result of the cuff pressure management. Since the primary outcome can't be measured by any method other than the investigational device, the study groups will be treated as follows:

* The Treatment group in this study will be treated with the fully functional AnapnoGaurd 100 device (per its intended use),

* The Control group will be treated with the AnapnoGuard device, where the cuff control will be disabled (off) and the cuff management will be done according to SOC.

Effectiveness will be measured by the duration and level of carbon dioxide (CO2) leakage around the endotracheal tube (ETT) cuff, from the lungs to the subglottic space and safety will be measured by adverse events (AEs).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-20
• Study Start: 2013-09
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Results First Submitted: 2016-09-06
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-21
• Last Update Submitted: 2017-05-21
• Results First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Age above 18 (men and women);
2. Subject is expected to receive mechanical ventilation for more than 12 hours;
3. Connection of the ETT to the AnapnoGuard system within 12 hours from intubation initiation;
4. Subject or subject's legally acceptable representative signed the Informed Consent Form

Exclusion Criteria

1. Subjects with facial, oropharyngeal or neck trauma 2. BMI>40 3. Pregnant women 4. Patient ventilated in prone position 5. Difficult intubation (defined as more than 3 intubation attempts)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CO2 Leakage Above the ETT Cuff, Measured Over Time.	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days	Trial outcome measure represents patients' exposure to CO2 leakage standardized per hour. Specifically, each patients' area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient's number of hours in the trial. Outcome measure is thus \[CO2 mmHg\*hour\]/hour.; CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading.

Secondary Outcome Measures

Name	Time	Method
Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days	mean number of cuff pressure measurements within the safety accepted range of 24 and 40 cmH2O, normalized using the total number of valid cuff pressure measurements.

Trial Locations

Locations (4)

Mayanei Hayeshua Medical Center, General ICU; 🇮🇱 Bnei Brak, Israel

Rambam Medical Center, Cardiac Surgery Department; 🇮🇱 Haifa, Israel

Rambam Medical Center, Neurosurgery Department; 🇮🇱 Haifa, Israel

Wolfson Medical Center, General ICU; 🇮🇱 Holon, Israel