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

NCT04222569 | Terminated

• 1 other identifier: RECHMPL19_0197
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Esophageal Pressure Time Product per minute (PTPes.min)

  Day two

• Esophageal Pressure Time Product per minute (PTPes.min)

  Day three

Other Outcomes (8)

• Tidal impedance variation (TIV) assessed with Electrical Impedance Tomography

  Day one

• End Expiratory Lung Impedance (EELZ) assessed with Electrical Impedance Tomography

  Day one

• Global inhomogeneity index (GI) assessed with Electrical Impedance Tomography

  Day one

Study Arms (6)

T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0

EXPERIMENTAL

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; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0

EXPERIMENTAL

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; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece

EXPERIMENTAL

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; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0

EXPERIMENTAL

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; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0

EXPERIMENTAL

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; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece

EXPERIMENTAL

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; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

Interventions

T-piece PROCEDURE

Spontaneous breath trial with a T-piece

PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece; PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0; PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece; PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0; T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0; T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0

PSV 7 and PEEP 0 PROCEDURE

Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure

PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece; PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0; PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece; PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0; T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0; T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0

PSV 0 and PEEP 0 PROCEDURE

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; PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0; PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece; PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0; T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0; T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, 34000, France

Location

Related Publications (2)

• 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.

  PMID: 27784322 BACKGROUND

• 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.

  PMID: 37438068 DERIVED

Study Officials

• Samir Jaber, MD, PHD

  Montpellier University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 10, 2020
• Study Start: June 15, 2020
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after the main publication
• 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.

Locations

FR (1)