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Physiological Study of Low-frequency HFO/HFO-TGI and High-frequency HFO

NCT02027129 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-08-17

No results posted yet for this study

Summary

Recent data from large trials of high-frequency high frequency oscillation (HFO) without a cuff leak vs, lung-protective conventional ventialtion (CMV) failed to show any HFO-related benefit with respect to outcome. A possible explanation is that HFO increases the probability of right ventricular dysfunction due to the combination of high mean airway pressures (mPaws) and hypercapnia. In contrast, available preliminary data on low-frequency HFO-tracheal gas insufflation (TGI) with cuff leak vs. CMV are suggestive of an HFO-TGI related benefit. Low-frequency HFO-TGI with a cuff leak is associated with relatively low mean tracheal pressures and adequate control of PaCO2. Thus, the investigators intend to test the hypothesis that low frequency HFO +/- TGI with a cuff leak is associated with better right ventricular function relative to high-frequency HFO without a cuff leak.

Conditions

  • Acute Respiratory Distress Syndrome
  • Acute Cor Pulmonale

Interventions

OTHER

High Frequency Oscillation

Comparison of low frequency HFO/HFO-TGI with cuff leak and high frequency HFO without cuff leak on right ventricular function

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D Mentzelopoulos, MD, PhD · University of Athens Medical School, Dept. Intensive Care Medicine

  • Spyros G Zakynthinos, MD, PhD · University of Athens Medical School, Dept. Intensive Care Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02027129 on ClinicalTrials.gov