Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation (NCT04222569) | Clinical Trial Compass
TerminatedNot Applicable
Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation
Stopped: sufficient number of patients to meet objectives
France117 participantsStarted 2020-06-15
Plain-language summary
Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ICU patient with invasive mechanical ventilation for at least 24 hours
* Physician decision to extubate and all criteria for ventilatory weaning must be present
* Resolution of disease acute phase for which the patient was intubated
* Conscious patient (Richmond Agitation-Sedation Scale (RASS) \> 0), no sedation
* Good coughing effort, good swallowing, positive leak test (\> 12% of tidal volume (VT))
* No important secretions
* No respiratory acidosis, adequate oxygenation (PaO2 / FiO2 \> 150 mmHg and CPAP ≤ 8)
* Adequate pulmonary function (respiratory rate (RR) ≤ 35, negative inspiratory force (NIF) \> 20 cmH2O, RR/VT \< 105)
* Stable cardiovascular status (heart rate (HR) \< 140 bpm, systolic blood pressure \> 90 mmHg, no or minimal vasopressors)
* If severe brain injury, the VISAGE score must be ≥ 3 (visual pursuit, good swallowing, GCS \> 10)
Exclusion Criteria:
* Obese patients with BMI ≥ 35 kg/m2
* Contraindication for nasogastric tube or esophageal manometric balloon placement
* Refusal of study participation or to pursue the study by the patient, no consent
* Pregnancy or breastfeeding
* Absence of coverage by the French statutory healthcare insurance system
What they're measuring
1
Esophageal Pressure Time Product per minute (PTPes.min)