Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation
NCT ID: NCT04222569
Last Updated: 2023-08-25
Study Results
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Basic Information
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TERMINATED
NA
117 participants
INTERVENTIONAL
2020-06-15
2023-06-15
Brief Summary
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Detailed Description
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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 unknown, 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Then, extubation is decided by clinician in charge, in accordance with guidelines. A 30 min of resting period is respected before. Data are recorded before and 20 minutes after extubation.
TREATMENT
NONE
Study Groups
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T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0
First T-piece trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min.
T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0
First T-piece trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min.
T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece
First PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min.
T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0
First PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min.
T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0
First PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min.
T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece
First PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min.
T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
Interventions
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T-piece
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Samir Jaber, MD, PHD
Role: STUDY_DIRECTOR
Montpellier University Hospital
Locations
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Centre Hospitalier Universitaire Saint Eloi
Montpellier, Herault, France
Countries
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References
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Mahul M, Jung B, Galia F, Molinari N, de Jong A, Coisel Y, Vaschetto R, Matecki S, Chanques G, Brochard L, Jaber S. Spontaneous breathing trial and post-extubation work of breathing in morbidly obese critically ill patients. Crit Care. 2016 Oct 27;20(1):346. doi: 10.1186/s13054-016-1457-4.
Capdevila M, De Jong A, Aarab Y, Vonarb A, Carr J, Molinari N, Capdevila X, Brochard L, Jaber S. Which spontaneous breathing trial to predict effort to breathe after extubation according to five critical illnesses: the cross-over GLOBAL WEAN study protocol. BMJ Open. 2023 Jul 12;13(7):e070931. doi: 10.1136/bmjopen-2022-070931.
Other Identifiers
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RECHMPL19_0197
Identifier Type: -
Identifier Source: org_study_id
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