CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
High Frequency Oscillationother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02027129
NCT02027129Phase 1Completed

Comparison of Cardio-respiratory Variables Between Low-frequency High Frequency Oscillation With/Without Tracheal Gas Insufflation and High-frequency High-frequency Oscillation in Severe ARDS.

University of Athens·interventional·Posted Jan 3, 2014·Updated Aug 17, 2017

In Brief

A Phase 1 clinical trial evaluating High Frequency Oscillation for Acute Respiratory Distress Syndrome and Acute Cor Pulmonale. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 3, 2014
Enrollment StartJan 1, 2014
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.5 years ago

Interventions

High Frequency Oscillationother

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