Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation

Study Overview
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Brief Summary
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Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study

Detailed Description
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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 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.

Official Title
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Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation: a Randomized and Personalized Cross Over Physiologic Study in the Perioperative and Critically Ill Patient

Conditions
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Intensive Care Unit, Invasive Mechanical Ventilation, Ready to Wean From Ventilation

Intervention / Treatment
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* Procedure: T-piece
* Procedure: PSV 7 and PEEP 0
* Procedure: PSV 0 and PEEP 0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each patient, serving as their own control, realize three SBT for 15 minutes: T-piece, PSV 7 cmH2O without PEEP and PSV 0 cmH2O without PEEP. The order is randomized. The randomization is stratified on pathology. For avoid a carry-over effect, a wash-out period of baseline ventilation for 10 minutes will be respected between trials. The humidification device is a heated humidifier, linked to the ventilator. Data are recorded before (guarantee of real return to baseline) and after each SBT. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0<br>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. | Procedure: T-piece<br>* Spontaneous breath trial with a T-piece<br>Procedure: PSV 7 and PEEP 0<br>* Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure<br>Procedure: PSV 0 and PEEP 0<br>* Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator<br>|
| Experimental: T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0<br>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. | Procedure: T-piece<br>* Spontaneous breath trial with a T-piece<br>Procedure: PSV 7 and PEEP 0<br>* Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure<br>Procedure: PSV 0 and PEEP 0<br>* Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator<br>|
| Experimental: PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece<br>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. | Procedure: T-piece<br>* Spontaneous breath trial with a T-piece<br>Procedure: PSV 7 and PEEP 0<br>* Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure<br>Procedure: PSV 0 and PEEP 0<br>* Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator<br>|
| Experimental: PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0<br>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. | Procedure: T-piece<br>* Spontaneous breath trial with a T-piece<br>Procedure: PSV 7 and PEEP 0<br>* Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure<br>Procedure: PSV 0 and PEEP 0<br>* Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator<br>|
| Experimental: PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0<br>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. | Procedure: T-piece<br>* Spontaneous breath trial with a T-piece<br>Procedure: PSV 7 and PEEP 0<br>* Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure<br>Procedure: PSV 0 and PEEP 0<br>* Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator<br>|
| Experimental: PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece<br>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. | Procedure: T-piece<br>* Spontaneous breath trial with a T-piece<br>Procedure: PSV 7 and PEEP 0<br>* Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure<br>Procedure: PSV 0 and PEEP 0<br>* Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal Pressure Time Product per minute (PTPes.min) | In cmH2O.s/min. Assessment of patient's inspiratory effort. Integration of esophageal swing pressure over time, performed with a second-generation balloon esophageal catheter, immediately before and after each spontaneous breathing trial, before and 20 min after extubation | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal Pressure Time Product per minute (PTPes.min) | In cmH2O.s/min. If esophageal catheter still in place, patient's inspiratory effort 24 hours after extubation | Day two | 
| Esophageal Pressure Time Product per minute (PTPes.min) | In cmH2O.s/min. If esophageal catheter still in place, patient's inspiratory effort 48 hours after extubation. | Day three | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Critical Care, Mechanical Ventilation Weaning, Spontaneous Breath Trial, Rehabilitation