MedTrace Logo

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

NCT07172061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-09-15

No results posted yet for this study

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?

Conditions

  • Mechanical Ventilation

Interventions

OTHER

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

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.

Sponsors & Collaborators

  • Fondazione IRCCS San Gerardo dei Tintori

    collaborator OTHER

  • AUSL Romagna Rimini

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • Italy

Study Locations

More Related Trials

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 NCT07172061 on ClinicalTrials.gov