Evaluating Air Leak Detection in Intubated Patients

A Study to Evaluate Air Leak Detection Above the Endotracheal Cuff in Intubated Patients Using the AnapnoGuard 100 System

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).

Study Overview

• Status: Completed
• Conditions: Critical Care
• Intervention / Treatment: Device: AnapnoGuard 100 control unit

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Bnei Brak, Israel
    • Mayanei Hayeshua Medical Center, General ICU
  • Haifa, Israel
    • Rambam Medical Center, Cardiac Surgery Department
  • Haifa, Israel
    • Rambam Medical Center, Neurosurgery Department
  • Holon, Israel
    • Wolfson Medical Center, General ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Subjects in the study group will be connected to the AnapnoGuard 100 control unit operating in the normal clinical mode (automatic CO2 leak measurement above the cuff, cuff pressure control, evacuation of secretions and tracheal rinsing)	Device: AnapnoGuard 100 control unit
Active Comparator: Control group; Subjects in the control group will be connected to the AnapnoGuard 100 control unit. In the control group, the cuff pressure control of the AnapnoGuard 100 control unit will be disabled (OFF). CO2 level above the cuff will be recorded. Suction and rinsing function will operate after the system detects no CO2.	Device: AnapnoGuard 100 control unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CO2 Leakage Above the ETT Cuff, Measured Over Time.	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.	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)	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.	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

Collaborators and Investigators

• Sponsor: Hospitech Respiration
• Investigators: Study Director: Shai Efrati, MD, Hospitech Respiration; Principal Investigator: Gil Bolotin, MD

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: May 21, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Critical care; Mechanical ventilation; Endotracheal intubation
• Other Study ID Numbers: HST-AG-07