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Evaluating Air Leak Detection in Intubated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857986
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hospitech Respiration

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).


Condition or disease Intervention/treatment Phase
Critical Care Device: AnapnoGuard 100 control unit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Air Leak Detection Above the Endotracheal Cuff in Intubated Patients Using the AnapnoGuard 100 System
Study Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Arm Intervention/treatment
Experimental: 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)
Device: AnapnoGuard 100 control unit
Active Comparator: 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.
Device: AnapnoGuard 100 control unit



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857986


Locations
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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, Israel
Sponsors and Collaborators
Hospitech Respiration
Investigators
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Study Director: Shai Efrati, MD Hospitech Respiration
Principal Investigator: Gil Bolotin, MD
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Responsible Party: Hospitech Respiration
ClinicalTrials.gov Identifier: NCT01857986    
Other Study ID Numbers: HST-AG-07
First Posted: May 20, 2013    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: May 2017
Keywords provided by Hospitech Respiration:
Endotracheal intubation
Mechanical ventilation
Critical care