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OpenTrials
Completed

NCT Number: NCT07717125

Accuracy of Physical Examination for Assessing Inspiratory Effort During Assisted Ventilation

The aim of this study is to assess whether clinical evaluation can accurately estimate the level of respiratory effort in intubated ICU patients receiving pressure support ventilation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Henri Mondor

Créteil, France

About this study

Insufficient or excessive respiratory effort during assisted ventilation contributes to diaphragm injury and patient self-inflicted lung injury (P-SILI), both of which worsen outcomes. Patients in the transition phase from controlled ventilation to assisted modes are particularly vulnerable because persistent lung injury may drive elevated respiratory effort, pendelluft, and large swings in alveolar pressure. One of the main goals of assisted ventilation is therefore to maintain effort within a physiological range that avoids both over- and under-assistance.

During pressure support ventilation (PSV), direct measurement of respiratory effort requires esophageal pressure monitoring, which is rarely feasible in routine care. Other noninvasive approaches, such as diaphragm ultrasound, lack reproducibility and cannot provide continuous monitoring. Airway occlusion pressure has shown promise for identifying both insufficient and excessive effort, but its performance varies across ventilator models. Additional indices, such as the maximal negative swing of airway pressure during end-expiratory occlusion (∆Pocc), or the pressure-muscle index (PMI), are limited by ventilator constraints.

In clinical practice, respiratory effort is usually judged clinically at the bedside. However, the accuracy of clinical examination for detecting abnormal effort has never been validated. The investigators hypothesize that bedside clinical assessment is unreliable and may expose patients to inappropriate levels of assistance. The primary aim of this investigation was to determine the accuracy of clinical examination in diagnosing abnormal respiratory effort during PSV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients mechanically ventilated for at least 48 hours
  • switched to pressure support ventilation within the previous 48 hours

Exclusion criteria

  • pregnancy
  • legal protection status
  • refusal by the patient or relatives to participate

Treatment and study plan

Clinical evaluation of the respiratory effort by the physician and nurse in charge of the patient

Diagnostic Test

The clinician and the nurse in charge of the patient evaluate the respiratory effort

Primary outcomes

  1. Diagnostic performance (sensitivity, specificity) of the clinical evaluation in diagnosing excessive respiratory effort and insufficient respiratory effort

    Time frame: Baseline

    The physician in charge of the patient will be asked to categorize the patient respiratory effort as normal, insufficient or excessive, based on his/her clinical evaluation.

    Esophageal pressure will be recorded at the same time, using an esophageal catheter. Esophageal pressure time product will then be computed and considered the reference standard for respiratory effort quantification. Sensitivity and Specificity of the clinical evaluation to diagnose excessive or insufficcient effort will be computed

Secondary outcomes

  1. Mortality

    Time frame: Day 28

    Mortality

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.