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Clinical Trials/NCT01550978
NCT01550978CompletedNot Applicable

The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients

Hospitech Respiration1 site in 1 country60 target enrollmentStarted: February 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Rate of AE (adverse events) and SAE (serious adverse events)

Study Overview

Brief Summary

The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age above 21 (men and women);
  • Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours
  • Absence of clear signs of pneumonia and lung contusion on chest X ray;
  • For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
  • No fever or fever from a known non chest/lung origin;

Exclusion Criteria

  • Patients who had been treated with mechanical ventilation during the last 3 months;
  • Patients with facial, oropharyngeal or neck trauma
  • BMI > 40
  • Pregnant women
  • Patients ventilated in prone position
  • Difficult intubation (defined as more than 3 intubation attempts)

Outcomes

Primary Outcomes

Rate of AE (adverse events) and SAE (serious adverse events)

Time Frame: participants will be followed for the entire duration of intubation (an expected average of 8 days)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospitech Respiration
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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