Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation (GLOBAL WEAN)

  • STATUS
    Recruiting
  • End date
    Jun 15, 2024
  • participants needed
    150
  • sponsor
    University Hospital, Montpellier
Updated on 6 May 2022

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

Description

Mechanical ventilation is the most used organ replacement therapy in intensive care unit (ICU). After resolution of acute illness, separating the ventilator from the patient may be specially challenging. Before extubation, it is recommended to perform a spontaneous breathing trial (SBT) to evaluate the ability to sustain breathing with minimal or no support.

The way to carry out this step of the weaning process present important variation across regions of the world. Two techniques are preferentially used : the T-piece trial (oxygen supply without positive pressure) and low pressure support ventilation (PSV) from 6 to 10 cmH2O according to the airway humidification device.

The best strategy for successful weaning remains unknow, especially about specific subgroups of respiratory and neurological diseases.

Our aim is to assess which spontaneous breathing trial would best reproduce post-extubation inspiratory effort. We compare T-piece trial, PSV 7 cmH2O without positive end expiratory pressure (PEEP) and PSV 0 cmH2O without PEEP. Five specific profiles are evaluated : chronic obstructive pulmonary disease (COPD), severe brain injury, blunt thoracic trauma, post abdominal surgery and miscellaneous.

The hypothesis is that T-piece trial and PSV 0 CPAP 0 trial are the best for mimic inspiratory effort after extubation. However, we could highlight various results according to different subgroups of ICU patients. The final aim is to determine a personalized wean trial for each.

Details
Condition Intensive Care Unit, Invasive Mechanical Ventilation, Ready to Wean From Ventilation
Treatment T-piece, PSV 7 and PEEP 0, PSV 0 and PEEP 0
Clinical Study IdentifierNCT04222569
SponsorUniversity Hospital, Montpellier
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

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
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