Clinical trial NCT04222569: Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intensive Care Unit
Invasive Mechanical Ventilation
Ready to Wean From Ventilation
Keywords: Intensive Care Unit
Critical Care
Mechanical Ventilation Weaning
Spontaneous Breath Trial
Rehabilitation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Esophageal Pressure Time Product per minute (PTPes.min)
timeFrame: Day one
Secondary outcomes:
measure: Esophageal Pressure Time Product per minute (PTPes.min)
timeFrame: Day two
measure: Esophageal Pressure Time Product per minute (PTPes.min)
timeFrame: Day three
Other outcomes:
measure: Tidal impedance variation (TIV) assessed with Electrical Impedance Tomography
timeFrame: Day one
measure: End Expiratory Lung Impedance (EELZ) assessed with Electrical Impedance Tomography
timeFrame: Day one
measure: Global inhomogeneity index (GI) assessed with Electrical Impedance Tomography
timeFrame: Day one
measure: Regional Ventilation Delay (RVD) index assessed with Electrical Impedance Tomography
timeFrame: Day one
measure: Subjective discomfort assessment with Numeric discomfort scale
timeFrame: Day one
measure: Objective discomfort assessment with respiratory rate > 30 per min
timeFrame: Day one
measure: Post extubation respiratory management
timeFrame: Day three
measure: Extubation success or failure
timeFrame: Day three
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire Saint Eloi
state: Herault
Study officials:
affiliation: Montpellier University Hospital
name: Samir Jaber, MD, PHD
role: STUDY_DIRECTOR
References:
citation: 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.