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Transpulmonary Pressure Gradients in High Frequency Oscillation (TPG in HFO)

This study is currently recruiting participants.
Verified December 2011 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01321398
First received: March 21, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Acute Lung Injury
 Other: Esophageal Pressure Monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transpulmonary Pressure Gradients in High Frequency Oscillation Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • To demonstrate the proof of concept that esophageal pressures can easily be obtained in patients undergoing HFO. [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the transpulmonary pressure gradient in critically ill patients receiving HFO [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Critically Ill patients receiving HFO 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Critically Ill

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321398

Contacts
Contact: William R Henderson, FRCPC 604-875-5949 william.henderson@vch.ca
Contact: Denise A Foster, RN, CCRP 604-875-4111 ext 68336 denise.foster@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Principal Investigator: William R Henderson, FRCPC            
Sub-Investigator: Donald EG Griesdale, FRCPC            
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: William R Henderson, FRCPC Universtiy of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01321398     History of Changes
Other Study ID Numbers: H10-02087
Study First Received: March 21, 2011
Last Updated: December 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
High Frequency Oscillation
Oscillation
HFO
Transpulmonary pressure

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013