Evaluating Air Leak Detection in Intubated Patients

Hospitech Respiration

Status: Completed

Conditions: Critical Care

Treatments: Device: AnapnoGuard 100 control unit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857986

HST-AG-07

Details and patient eligibility

About

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).

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Study group

Experimental group

Description:

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)

Treatment:

Device: AnapnoGuard 100 control unit

Control group

Active Comparator group

Description:

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.

Treatment:

Device: AnapnoGuard 100 control unit