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

Intensive Care Unit Clinical Trial

— GLOBAL WEAN  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04222569
• Other study ID #: RECHMPL19_0197
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: June 15, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit
• Invasive Mechanical Ventilation
• Ready to Wean From Ventilation

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Saint Eloi	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tidal impedance variation (TIV) assessed with Electrical Impedance Tomography	In unit of impedance change (AU). Assessment of pulmonary volumes, only for the patients included in the center of Saint Eloi University hospital (ancillary study), immediately before and after each spontaneous breathing trial, before and 20 min after extubation.	Day one
Other	End Expiratory Lung Impedance (EELZ) assessed with Electrical Impedance Tomography	In unit of impedance change (AU). Assessment of pulmonary volumes, only for the patients included in the center of Saint Eloi University hospital (ancillary study), immediately before and after each spontaneous breathing trial, before and 20 min after extubation.	Day one
Other	Global inhomogeneity index (GI) assessed with Electrical Impedance Tomography	In percentage. Assessment of pulmonary volumes, only for the patients included in the center of Saint Eloi University hospital (ancillary study), immediately before and after each spontaneous breathing trial, before and 20 min after extubation.	Day one
Other	Regional Ventilation Delay (RVD) index assessed with Electrical Impedance Tomography	Assessment of pulmonary volumes, only for the patients included in the center of Saint Eloi University hospital (ancillary study), immediately before and after each spontaneous breathing trial, before and 20 min after extubation.	Day one
Other	Subjective discomfort assessment with Numeric discomfort scale	Visual numeric scale from 0 (no discomfort) to 10 (worst discomfort experienced), before and after each spontaneous breathing trial	Day one
Other	Objective discomfort assessment with respiratory rate > 30 per min	Before and after each spontaneous breathing trial	Day one
Other	Post extubation respiratory management	Physiotherapy (yes or no), oxygen therapy (yes or no, parameters), noninvasive ventilation (yes or no, parameters), the day of extubation, at 24h and 48h post extubation	Day three
Other	Extubation success or failure	Extubation success (no reintubation) or failure (reintubation) within 48h after extubation.	Day three
Primary	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	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
Secondary	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