Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients

NCT06867354 | Recruiting

• 2 other identifiers: APHP241581IDRCB-2024-A02501-46
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

ICU patients encounter numerous discomforts, with dyspnea (the sensation of breathlessness) being among the most distressing and impactful. Unlike pain, dyspnea in ICU settings has historically received limited attention, despite its severe psychological impact. ICU clinicians often use assessment tools like the simple numerical dyspnea scale (Dyspnea-VAS) and the Respiratory Distress Observation Scale (MV-RDOS) to measure dyspnea. These scales are also utilized during the weaning process, an essential phase when patients attempt to breathe independently without ventilator assistance. Weaning is crucial for ICU patients, as delayed or unsuccessful extubation increases the risk of complications and mortality. Obese ICU patients, often admitted due to respiratory failure, present unique challenges due to physiological changes in the respiratory system, such as reduced functional residual capacity and decreased lung compliance. These factors contribute to an increased likelihood of dyspnea and weaning complications. Approximately 50% of obese ICU patients require mechanical ventilation, and once ventilated, obese patients exhibit an elevated risk for dyspnea and ventilator weaning failure. Understanding the prevalence, causes, and consequences of dyspnea and failure in weaning process in obese ICU patients is critical. In this study, the aim is to compare obese patients with non-obese patients in terms of dyspnea prevalence, causes and consequences as weaning failure prevalence, causes and consequences.

Conditions

Obesity; Obesity With Complications; Weaning From Mechanical Ventilation in Care Unit; Dyspnea

Keywords

Intensive Care Unit; Dyspnea; Mechanical Ventilation; Ventilatory Weaning; Obesity; Spontaneous Ventilation Test; Mortality

Outcome Measures

Primary Outcomes (1)

• Presence or onset of dyspnea

  Presence or onset of dyspnea detected by the simple numerical dyspnea scale (Dyspnea-Visual Analog Scale VAS) from 0 to 10 cm , 0 means "no respiratory discomfort, no sensation of shortness of breath, no difficulty breathing" and 10 means "the worst imaginable respiratory discomfort, feeling of shortness of breath, inability to breathe" ≥ 4 before, and then at 2 minutes, 15 minutes, 30 minutes, and at the end of SBT. In order to describe the prevalence of dyspnea during the first SBT in obese patients hospitalized in the ICU compared to non-obese patients.

  Baseline

Secondary Outcomes (34)

• Measure of the affective component of dyspnea using the simple numerical dyspnea scale

  Baseline

• : Presence or onset of dyspnea detected by the Mechanical Ventilation - Respiratory Distress Observation Scale

  Baseline

• Measure of Rapid Shallow Breathing Index (RSBI) (the ratio of respiratory frequency (f) to tidal volume (TV)) measured at 1 minute of SBT > 105 breaths/min/L.

  Baseline

• Measure of Pain with Visual Analog Scale (VAS) for pain from 1 to 100 mm (1 means no pain, 100 means major pain)

  Baseline

• Research of anxiety with Hospital Anxiety and Depression Scale (HADS) from 0 to 21, 0 means no anxiety, 21 means major anxiety, anxiety if HADS > 8

  Baseline

Study Arms (2)

Patients with (BMI of ≥30 kg/m²) obesity

Patients without obesity

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

Patients hospitalized in intensive care under mechanical ventilation for at least 48 hours, with or without obesity (BMI \> 30 kg/m²).

You may qualify if:

• Patients placed on mechanical ventilation for at least 48 hours
• On spontaneous ventilation mode with inspiratory support (only possible ventilation mode during ventilation weaning) allowing a tidal volume \> 6 mL/kg and a positive end-expiratory pressure set by the attending physician between 5 and 8 cmH2O
• Decision by the attending physician to perform a spontaneous breathing trial (SBT) after verifying the prerequisites for weaning: resolution of the acute phase of the illness for which the patient is placed on invasive mechanical ventilation, low bronchial congestion, adequate cough, adequate oxygenation defined by SpO2 \> 90% with FiO2 ≤ 40% and PEEP ≤ 8 cmH2O, respiratory rate ≤ 40 breaths/min, Ramsay sedation score \< 4, and stable cardiovascular state (heart rate ≤ 120 beats/min, systolic blood pressure ≤ 180 mmHg, and no or minimal vasopressors \[norepinephrine \< 5 μg/kg/min\])
• After information,no opposition from the patient or the relative (if the patient is unable to express his non opposition) to participating in the research
• Person affiliated with a social security regime or eligible
• Patient with a BMI \> 30 kg/m² for those included in the case group (obesity)

You may not qualify if:

• Under 18 years old
• Pregnant or breastfeeding women
• Patients for whom weaning is impossible (pre-existing neuromuscular disorders, cervical spinal cord lesions)
• Patients for whom repeated dyspnea assessment is likely to be difficult (known history of cognitive or psychiatric disorders, delirium, Richmond Agitation-Sedation Scale score less than -2 or greater than 2)
• Patients under legal protection measures (guardianship, curatorship)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Intensive-Réanimation Hôpital Tenon, AP-HP

Paris, Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Obesity; Dyspnea

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Central Study Contacts

Alexandra BEURTON, Doctor

CONTACT

00 33 6 23 08 64 88; alexandra.beurton@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: March 10, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (1)