Evaluating Air Leak Detection in Intubated Patients

NCT ID: NCT01857986

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-06-30

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).

Conditions

Critical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

AnapnoGuard 100 control unit

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

AnapnoGuard 100 control unit

Intervention Type: DEVICE

Interventions

AnapnoGuard 100 control unit

Intervention Type: DEVICE

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitech Respiration

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shai Efrati, MD

Role: STUDY_DIRECTOR

Hospitech Respiration

Gil Bolotin, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

Israel

Other Identifiers

HST-AG-07

Identifier Type: -

Identifier Source: org_study_id