CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)other
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07172061
NCT07172061N/ACompleted

Sigh in Pressure Support Ventilation to Detect Respiratory System Compliance and Lung Recruitability

AUSL Romagna Rimini·interventional·Posted Sep 15, 2025·Updated Sep 15, 2025

In Brief

A clinical study evaluating PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) for Mechanical Ventilation. Completed, enrolled 110 participants across 2 sites.

Detailed Summary

The goal of this physiological study is to determine whether ventilator-delivered sigh breaths during pressure support ventilation (PSV) provide a reliable bedside index of lung recruitability and can guide PEEP optimization.The main questions it aims to answer are: * Does respiratory system compliance measured at the end of a sigh (Crs\_sigh) differ from compliance obtained with an inspiratory hold during an assisted breath (Crs\_assisted), and can the Crs\_sigh/Crs\_assisted ratio indicate recruitability? * Does adjusting PEEP based on the sigh-derived recruitability index improve respiratory mechanics and gas exchange compared with usual clinical PEEP settings?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20252026
First PostedSep 15, 2025
Enrollment StartJul 30, 2024
Primary CompletionMay 31, 2025
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10 months ago

Interventions

PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O)other

Each patient undergoes two sequential 15-minute steps: 1) pressure support ventilation at the clinical PEEP and 2) the same settings with PEEP increased by 3 cmH₂O. A ventilator-delivered sigh is programmed as one sustained inflation at 30 cmH₂O for 3 seconds every minute. All other ventilator parameters (trigger sensitivity, pressure support level, mandatory breath timing) remain unchanged. At the end of each step, inspiratory and expiratory holds are performed to collect respiratory mechanics and arterial blood gases; compliance during the sigh is calculated once flow is zero and airway pressure is stable.