Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients (WEAN OBESE)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06867354

IDRCB-2024-A02501-46 (Other Identifier)

APHP241581

Details and patient eligibility

About

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.

Full description

Research Justification:

ICU patients face numerous sources of discomfort, among which dyspnea- the subjective sensation of breathlessness-stands out as especially distressing. Unlike pain, dyspnea has historically received limited attention, despite its severe psychological impact, including feelings of panic and death anxiety. Dyspnea integrates both physical and psychological suffering, often leading patients to report it as one of the most unbearable experiences, highlighting its significance for ICU caregivers. The subjective nature of dyspnea presents a diagnostic challenge, as it may occur without visible respiratory distress, which complicates detection and management. Dyspnea arises from complex mechanisms, including increased respiratory muscle load from airway resistance or thoracic compliance reduction. Additionally, dyspnea can be induced by an increased need for air due to elevated carbon dioxide levels or reduced oxygen levels, triggering chemoreceptor responses.

For ICU patients mechanically ventilated, the prevalence of dyspnea has been reported between 34 and 47%. Dyspnea assessment tools, such as the Dyspnea-VAS (Visual Analog Scale) and the MV-RDOS (Respiratory Distress Observation Scale), are employed to measure dyspnea, even in intubated patients. These tools are especially useful during ventilator weaning, a critical phase when patients transition to spontaneous breathing. The weaning process, and particularly the spontaneous breathing test (SBT), a test during which the patient breath with the assistance of the ventilator, is critical. The failure of a SBT can increase mortality risk, length of mechanical ventilation and ICU stay.

In this study, the investigators focus in obesity. The growing prevalence of obesity adds an additional layer of complexity to ICU care, as obese patients present distinct challenges during ventilation and weaning. With physiological changes such as reduced lung compliance and increased airway resistance, obese patients have an elevated risk for dyspnea and ventilator weaning complications. Obesity prevalence surged during the COVID-19 pandemic until 40% of ICU patients, and today, up to 50% of obese ICU patients require mechanical ventilation.

In ICU obese patients and mechanically ventilated, there is no assessment of dyspnea, its determinants and its impact during ventilatory weaning. The pathophysiology of dyspnea and SBT failure is complex and primarily involves cardiac function and respiratory muscle function. Pulmonary edema is found in more than half of cases and is linked to the transition from a positive pressure ventilation regime to a negative pressure regime, which creates unfavorable loading conditions for the heart. The second cause described is diaphragmatic dysfunction characterized by atrophy of the respiratory muscles which can occur rapidly under mechanical ventilation. More recently, dyspnea has been described as a cause of SBT and extubation failure in its own right. Other causes have also been described such as intensive care neuropathy, iatrogenic causes (agitation, pain), anxiety, or even impaired ventilatory control.

In addition, the consequences of dyspnea and failure of SBT as well as their management are not described, such as the duration of mechanical ventilation, mortality, length of stay, intercurrent events such as new sepsis. or the administration of new treatments during the period from weaning to extubation.

Finally, the evolution of dyspnea after successful SBT and after extubation has never been described.

The prevalence, determinants and consequences of dyspnea and failure of the first SBT as well as their management in ICU patients with obesity have never been described. Likewise, improving the diagnostic performance of the clinical criteria for SBT failure with the contribution of dyspnea scales is a real challenge in these patients.

Research Design and Methodology:

Study Type: This is a descriptive, monocentric and comparative study.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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)

Trial design

80 participants in 2 patient groups

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

Patients without obesity