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Transpulmonary Pressure Gradients in High Frequency Oscillation

Transpulmonary Pressure Gradients in High Frequency Oscillation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01321398
Acronym
TPG in HFO
Enrollment
7
Registered
2011-03-23
Start date
2010-10-31
Completion date
2013-03-31
Last updated
2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury

Keywords

High Frequency Oscillation, Oscillation, HFO, Transpulmonary pressure

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.

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.

Interventions

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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To demonstrate the proof of concept that esophageal pressures can easily be obtained in patients undergoing HFO.60 minutes

Secondary

MeasureTime frame
To determine the transpulmonary pressure gradient in critically ill patients receiving HFO60 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026