Evaluating Air Leak Detection in Intubated Patients

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).

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Key information

Conditions

Critical Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayanei Hayeshua Medical Center, General ICU, Bnei Brak, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

AnapnoGuard 100 control unit

Device

Primary outcomes

CO2 Leakage Above the ETT Cuff, Measured Over Time.

Time frame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

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.

Secondary outcomes

Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)

Time frame: Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days

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.

Sponsors and collaborators

Lead sponsor

Hospitech Respiration

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: May 20, 2013
Registry last updated: Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed