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

Not Applicable

Terminated

• Conditions: Invasive Mechanical Ventilation; Intensive Care Unit; Ready to Wean From Ventilation
• Interventions: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0

• Registration Number: NCT04222569
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-10
• Study Start: 2020-06-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0	PSV 0 and 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.
T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0	T-piece	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.
T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0	PSV 7 and 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.
PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0	PSV 7 and 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.
T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0	T-piece	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.
T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0	PSV 7 and 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.
PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0	PSV 0 and 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.
PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0	T-piece	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.
PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0	T-piece	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.
PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece	PSV 7 and PEEP 0	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.
T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0	PSV 0 and 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.
PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece	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.
PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece	PSV 7 and PEEP 0	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.
PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0	PSV 0 and 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.
PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece	PSV 0 and PEEP 0	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.
PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece	PSV 0 and PEEP 0	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.
PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece	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.
PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0	PSV 7 and 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.

Primary Outcome Measures

Name	Time	Method
Esophageal Pressure Time Product per minute (PTPes.min)	Day one	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

Secondary Outcome Measures

Name	Time	Method
Esophageal Pressure Time Product per minute (PTPes.min)	Day three	In cmH2O.s/min. If esophageal catheter still in place, patient's inspiratory effort 48 hours after extubation.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Saint Eloi; 🇫🇷 Montpellier, Herault, France