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

University Hospital, Montpellier117 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

117

Conditions

Intensive Care Unit Invasive Mechanical Ventilation Ready to Wean From Ventilation

Interventions

T-piecePROCEDURE

Spontaneous breath trial with a T-piece

PSV 7 and PEEP 0PROCEDURE

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

PSV 0 and PEEP 0PROCEDURE

Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, France

Outcomes

Primary Outcomes

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

Time frame: Day one

Secondary Outcomes

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

Time frame: 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.

Time frame: Day three

Data from ClinicalTrials.gov

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