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Completed

NCT Number: NCT01321398

Transpulmonary Pressure Gradients in High Frequency Oscillation

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.

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Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 60 minutes

Secondary outcomes

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

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Transpulmonary Pressure Gradients in High Frequency Oscillation Study

Acronym: TPG in HFO

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Mar 23, 2011
Registry last updated
Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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