Transpulmonary Pressure Gradients in High Frequency Oscillation

NCT01321398 | Completed

• 1 other identifier: H10-02087
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lung Injury

Keywords

High Frequency Oscillation; Oscillation; HFO; Transpulmonary pressure

Outcome Measures

Primary Outcomes (1)

• To demonstrate the proof of concept that esophageal pressures can easily be obtained in patients undergoing HFO.

  60 minutes

Secondary Outcomes (1)

• To determine the transpulmonary pressure gradient in critically ill patients receiving HFO

  60 minutes

Study Arms (1)

Critically Ill patients receiving HFO

Other: Esophageal Pressure Monitoring

Interventions

Esophageal Pressure Monitoring OTHER

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.

Critically Ill patients receiving HFO

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically Ill

You may qualify if:

• years of age or older
• Receiving HFO
• Informed Consent Obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• William R Henderson, FRCPC

  Universtiy of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 23, 2011
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: March 1, 2013
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)