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

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

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

Study Overview

• Status: Terminated
• Conditions: Intensive Care Unit; Invasive Mechanical Ventilation; Ready to Wean From Ventilation
• Intervention / Treatment: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey De Jong, MD, PHD; Phone Number: 0033467337271; Email: a-de_jong@chu-montpellier.fr
• Study Contact Backup: Name: Samir Jaber, MD, PhD; Phone Number: 0033467337271; Email: s-jaber@chu-montpellier.fr

Study Locations

• France
  • Herault
    • Montpellier, Herault, France, 34000
      • Centre Hospitalier Universitaire Saint Eloi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: T-piece; Spontaneous breath trial with a T-piece; Procedure: PSV 7 and PEEP 0; Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure; Procedure: 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
Experimental: 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.	Procedure: T-piece; Spontaneous breath trial with a T-piece; Procedure: PSV 7 and PEEP 0; Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure; Procedure: 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
Experimental: 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.	Procedure: T-piece; Spontaneous breath trial with a T-piece; Procedure: PSV 7 and PEEP 0; Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure; Procedure: 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
Experimental: 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.	Procedure: T-piece; Spontaneous breath trial with a T-piece; Procedure: PSV 7 and PEEP 0; Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure; Procedure: 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
Experimental: 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.	Procedure: T-piece; Spontaneous breath trial with a T-piece; Procedure: PSV 7 and PEEP 0; Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure; Procedure: 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
Experimental: 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.	Procedure: T-piece; Spontaneous breath trial with a T-piece; Procedure: PSV 7 and PEEP 0; Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure; Procedure: 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Objective discomfort assessment with respiratory rate > 30 per min	Before and after each spontaneous breathing trial	Day one
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
Extubation success or failure	Extubation success (no reintubation) or failure (reintubation) within 48h after extubation.	Day three

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Samir Jaber, MD, PHD, Montpellier University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Intensive Care Unit; Critical Care; Mechanical Ventilation Weaning; Spontaneous Breath Trial
• Other Study ID Numbers: RECHMPL19_0197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual patient data will be made available upon a reasonable request
• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No