Evaluating Air Leak Detection in Intubated Patients

NCT01857986 | Completed Results

• 1 other identifier: HST-AG-07
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

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

Keywords

Endotracheal intubation; Mechanical ventilation; Critical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

AnapnoGuard 100 control unit DEVICE

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Hospitech Respiration: lead

Study Sites (4)

Mayanei Hayeshua Medical Center, General ICU

Bnei Brak, Israel

Location

Rambam Medical Center, Cardiac Surgery Department

Haifa, Israel

Location

Rambam Medical Center, Neurosurgery Department

Haifa, Israel

Location

Wolfson Medical Center, General ICU

Holon, Israel

Location

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Hospitech Respiration

adir@hospitech.co.il

+972-3-9191648

Study Officials

• Shai Efrati, MD

  Hospitech Respiration

  STUDY DIRECTOR

• Gil Bolotin, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 19, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-05

Locations

IL (4)