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CompletedNCT07717125Updated Jul 21, 2026

Accuracy of Physical Examination for Assessing Inspiratory Effort During Assisted Ventilation

An observational study in Patients Invasively Ventilated Under Pressure Support Ventilation, sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Centre Hospitalier Saint Joseph Saint Luc de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Patients Invasively Ventilated Under Pressure Support Ventilation
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In context

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

). Adult patients mechanically ventilated for at least 48 hours were eligible if switched to pressure support ventilation within the previous 48 hours. Exclusion criteria were pregnancy, legal protection status, and refusal by the patient or relatives to participate

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testClinical evaluation of the respiratory effort by the physician and nurse in charge of the patient

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

06

What researchers measure

Primary outcomes

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

    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

    Time frame: Baseline

Secondary outcomes

  1. Mortality

    Mortality

    Time frame: Day 28

07

Study locations

1 site
  • Hôpital Henri Mondor
    Créteil, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07717125
Lead sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Mar 11, 2019
Primary completion
Dec 21, 2022
Completion
Jan 21, 2023
Last update
Jul 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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