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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01321398
Other study ID # H10-02087
Secondary ID
Status Completed
Phase N/A
First received March 21, 2011
Last updated March 14, 2014
Start date October 2010
Est. completion date March 2013

Study information

Verified date March 2014
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

Patients with severe lung conditions occasionally require support with a special ventilator (breathing machine) called the High Frequency Oscillator (HFO). Effective ventilation requires that the pressure generated by the ventilator be as high as possible but not too high as this can damage the lungs. In patients on HFO, there is not a well defined way to measure this pressure. We will insert a small probe into the esophagus of patients on HFO to see if this is an accurate way to measure lung pressures for these patients. A better understanding of these pressures could lead to improved patient care.


Description:

Trials have found that the use of lower tidal volumes (6 ml/kg) during conventional mechanical ventilation decreases morbidity and mortality. Compared to conventional ventilation, high frequency oscillation (HFO) is able to provide much smaller tidal volumes (1.1 - 2.5 ml/kg) and thus theoretically may provide additional lung protection. At this time, while trials of HFO in adults have been inconclusive, the use of HFO for the management of ALI/ARDS has become widespread

Patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) are critically ill and have a high mortality associated with their illness (approximately 50%). Currently, esophageal pressure monitors are used to optimize inflation pressures and improve oxygenation in conventional mechanical ventilation in patients with ALI/ARDS. With this in mind, the purpose of this study is twofold: (1) demonstrate that esophageal pressure monitors can easily be inserted in patients undergoing HFO and (2) report the transpulmonary pressures in these patients.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date March 2013
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- 19 years of age or older

- Receiving HFO

- Informed Consent Obtained

Exclusion Criteria:

- Esophageal lesions or esophageal surgery within the last 6 months

- Morbid obesity - defined as a Body Mass Index (BMI) > 40

- Unstable cervical spine injury or cervical spinal cord injury

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Esophageal Pressure Monitoring
An esophageal pressure monitor will be placed through the mouth into the esophagus by a study physician. Placement will be confirmed by a bedside chest X-ray. Once placement has been confirmed all air will be evacuated from the balloon by syringe. One ml of air will then be injected to partially inflate the esophageal balloon. Pleural pressure measurements will be recorded after 1 minute without spontaneous breathing or patient care related movement. This measurement will be repeated at 30 minutes and at 60 minutes after the first measurement. Trans-pulmonary pressure is calculated as the difference between esophageal pressure and mouth pressure. Once the measurements have been recorded, the catheter will be removed.

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To demonstrate the proof of concept that esophageal pressures can easily be obtained in patients undergoing HFO. 60 minutes No
Secondary To determine the transpulmonary pressure gradient in critically ill patients receiving HFO 60 minutes No
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