Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients hospitalized in intensive care under mechanical ventilation for at least 48 hours, with or without obesity (BMI \> 30 kg/m²).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Patients with (BMI of ≥30 kg/m²) obesity
Group B: Patients without obesity
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
Measure of the affective component of dyspnea using the simple numerical dyspnea scale
Measure of the affective component of dyspnea using the simple numerical dyspnea scale (Dyspnea-Visual Analog Scale VAS) from 0 to 10, 0 means "no anxiety related to dyspnea" and10 means "maximum anxiety related to dyspnea" before, and then at 2 minutes, 15 minutes, 30 minutes, and at the end of SBT, anxiety if Dyspnea-VAS \> 4, in order to describe the prevalence of dyspnea during the first SBT in obese patients hospitalized in the ICU compared to non-obese patients.
Time frame
Baseline2
: Presence or onset of dyspnea detected by the Mechanical Ventilation - Respiratory Distress Observation Scale
Presence or onset of dyspnea detected by the Mechanical Ventilation - Respiratory Distress Observation Scale (MV-RDOS) in mechanically ventilated in non-communicating patients from 0 to 5, 0 means no dyspnea and 5 means major dyspnea, before SBT then at 2 minutes, 15 minutes, 30 minutes, and at the end of SBT, dyspnea if MV-RDOS\> 2.6, in order to describe the prevalence of dyspnea during the first SBT in obese patients hospitalized in the ICU compared to non-obese patients.
Time frame
Baseline3
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.
Measure of Rapid Shallow Breathing Index (RSBI) in order to describe the prevalence of dyspnea during the first SBT in obese patients hospitalized in the ICU compared to non-obese patients.
Time frame
Baseline4
Measure of Pain with Visual Analog Scale (VAS) for pain from 1 to 100 mm (1 means no pain, 100 means major pain)
Measure of pain in order to describe the main determinants of dyspnea during the first SBT in ICU patients and affected (case) or not (control) by obesity
Time frame
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Source ClinicalTrials.gov