Dyspnea and Cerebral Cortex Activation Measured by fNIRS During Spontaneous Breathing Trial

NCT06211738 | Completed

• 1 other identifier: APHP240001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In Intensive Care Unit (ICU) patients, dyspnea is frequent, severe and exerts unfavorable effects on the short, medium and long term. Detection and quantification rely on the patient's self-reporting abilities. However, more than half of the patients in the ICU are unable to report their sensations. Therefore, the risk is to miss the evaluation of dyspnea and the potential benefits associated with its control. Observational scales, based on physiological and behavioral changes related to dyspnea (such as the Mechanical Ventilation Respiratory Distress Observational Scale MV-RDOS), are promising alternative tools for the detection of dyspnea in non-communicating patients. However, their routine use is not standardized, is not supported by any recommendation, but above all, relies largely on the subjective observation of the facial expression of fear or the abdominal paradox. There is a need for alternatives to the visual analogue dyspnea scale (D-VAS) for the detection of dyspnea in non-communicating intubated patients. Analysis of brain cortical activity modifications during dyspnea could be an alternative to the dyspnea self-report (D-VAS) in the ICU and could improve the performance of observational dyspnea scales. Hypothesis: 1) dyspnea during a spontaneous breathing trial (SBT) is associated with premotor cortex activation identifiable using functional Near-Infrared Spectroscopy (fNIRS); 2) replacing the items "abdominal paradox" or "facial expression of fear" by HbO2 level could improve the performance of the MV-RDOS to predict dyspnea in non-communicating intubated patients; 3) HbO2 level change identified using fNIRS performs well in predicting SBT outcome

Conditions

Dyspnea

Keywords

Dyspnea; Ventilator weaning; Mechanical ventilation; Critical care; Functional Near-Infrared Spectroscopy; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and clinically significant dyspnea

  Clinically important dyspnea defined by a D-VAS \> 30 mm for communicating patients and MV-RDOS ≥ 2.6 for all patients.

  at inclusion

Secondary Outcomes (2)

• Associations between cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) and dyspnea intensity

  at inclusion

• Ability of cerebral cortex activation indices measured by fNIRS (HbO2 and HbR) to predict SBT outcome

  at seven days post inclusion

Other Outcomes (1)

• Associations between cerebral cortex activation indices measured by EEG (pre-inspiratory potentials) and SBT outcome

  at inclusion

Study Arms (1)

People with clinical dyspnea

Any intensive care patient undergoing invasive mechanical ventilation deemed suitable for ventilatory weaning test.

Other: no intervention

Interventions

no intervention OTHER

no intervention

People with clinical dyspnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any intensive care patient undergoing invasive mechanical ventilation deemed suitable for a ventilatory weaning test

You may qualify if:

• Invasive mechanical ventilation \> 24h
• Ability to realize a spontaneous breathing trial, defined by the following criteria: Effective cough, no excessive tracheo-bronchial secretions, resolution of the disease that prompted the intubation, heart rate ≤ 140/min, pressure systolic blood pressure between 90 and 160 mmHg, no or very low dose of amines, SpO2 \> 90% in 40% FiO2 (or PaO2/FiO2 \> 150), positive expiratory pressure \< 8 cmH2O, respiratory rate ≤ 35/min, tidal volume \> 5ml/kg of theoretical body weight, respiratory rate / tidal volume ratio \< 105 cycles/min/L
• Decision by the clinician in charge of the patient to perform a SBT,
• Patient or relative consent obtained.

You may not qualify if:

• Minor patient,
• Pregnant or breastfeeding woman
• Agitation/sedation: RASS ( Richmond Agitation-Sedation Scale) \> 2 or \< 2,
• Person under legal protection (guardianship, curators), safeguarded by justice.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Intensive Réanimation du département R3S, hôpital Pitié salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maxens DECAVELE, MD

  GHU APHP- Sorbonne Université

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 18, 2024
• Study Start: May 3, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)