Evaluating Air Leak Detection in Intubated Patients

Critical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857986
• Other study ID #: HST-AG-07
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: August 4, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Hospitech Respiration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Care

Intervention

Device:
• AnapnoGuard 100 control unit

Locations

Country	Name	City	State
Israel	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospitech Respiration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• Adverse events (AEs) in the study and control group	All adverse events including serious adverse events whether or not related to study device, including VAP and tracheal mechanical complications	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days and 48 hours post intubation	Yes
Primary	Verifying the effectiveness of the AnapnoGuard 100 system in continuously controlling endotracheal cuff pressure and monitoring of carbon dioxide concentration in the subglottic space	Overall duration and level of CO2 leakage, as assessed by the Area under the curve (AUC) of CO2 leakage over time	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days	No
Secondary	Verifying the effectiveness of the AnapnoGuard 100 system in continuously controlling endotracheal cuff pressure within the safety accepted range (24-40 cmH2O)	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	No
Secondary	Verifying the effectiveness of the AnapnoGuard 100 system in continuously controlling endotracheal cuff pressure thus minimizing the frequency of CO2 leakage above 2 mmHg (large leak) above the cuff	Number of CO2 leakage readings at or above 2 mmHg	Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days	No