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.

Study Overview

• Status: Completed
• Conditions: Patients Invasively Ventilated Under Pressure Support Ventilation
• Intervention / Treatment: Diagnostic test: Clinical evaluation of the respiratory effort by the physician and nurse in charge of the patient

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Créteil, France
    • Hopital Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	Day 28

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): January 21, 2023

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CLINASSEF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No