N/A N=76 Randomized Single-blind Prevention

Evaluating Air Leak Detection in Intubated Patients

Critical Care

Bottom Line

View on ClinicalTrials.gov: NCT01857986 ↗

Enrolled (actual)

Serious AEs

9.7%

Results posted

Jun 2017

Primary outcome: Primary: CO2 Leakage Above the ETT Cuff, Measured Over Time. — 0.09; 0.22 [CO2 mmHg*hour]/hour

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AnapnoGuard 100 control unit (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospitech Respiration
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY CO2 Leakage Above the ETT Cuff, Measured Over Time.	0.09; 0.22	—
SECONDARY Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)	0.979; 0.397	—

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).

Eligibility Criteria

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)

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Data sourced from ClinicalTrials.gov (NCT01857986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.