CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
PSP +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03041402
NCT03041402N/ACompleted

New Setting of Neurally Adjusted Ventilatory Assist During Postextubation Prophylactic Noninvasive Ventilation Through a Mask: a Physiologic Study

Southeast University, China·interventional·Posted Feb 2, 2017·Updated Feb 2, 2017

In Brief

A clinical study evaluating PSP, NAVA, and 1 other intervention for Acute Respiratory Failure and Mechanical Ventilation Complication. Completed, enrolled 14 participants.

Detailed Summary

Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal, i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance, improves patient-ventilator interaction. A specific setting to generate neurally controlled Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony. Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of asynchrony, as assessed by the Asynchrony Index (AI%).

Study Details

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

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2017
Enrollment StartMar 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.4 years ago

Interventions

PSPother

PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow

NAVAother

NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O

PSNother

PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP