Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient

The decision to extubate a patient after acute respiratory failure is based on clinical observation and measurement of pulmonary mechanics. Current extubation criteria(tidal volume, respiratory frequency...) lack of specificity. The best way to evaluate and predict patients breathing abilities after extubation is to challenge him to a spontaneous breathing trial (SBT) with endotracheal tube in place immediately before extubation to predict the patient's ability to breathe spontaneously after extubation. The intention is to approximate, while the patient is still intubated, the work of breathing that will be required of the patient after extubation. Different approaches of ventilatory settings are currently used for the preextubation SBT, whether pressure support ventilation (PSV), continuous positive airway pressure (CPAP), or spontaneous ventilation through an endotracheal tube (T piece), all supported by literature with different benefits. To the investigators knowledge, few studies define which mode of ventilation most closely approximates the work of breathing during spontaneous respiration after extubation, and none have studied a specific population of obese patient in respiratory weaning. The main objective of the investigators study is to determine, between five different SBT, which one is the best to approximate the work of breathing of obese patient after extubation.

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Key information

Conditions

Obesity Body Weight CPAP 7 cmH2O Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight PSV 0 cmH20 PEEP 0 cmH2O PSV 7 cmH2O PEEP 0 cmH20 PSV 7cmH2O PEEP 7cmH2O Pathological Conditions, Signs and Symptoms Post-extubation in Spontaneous Breathing and/or in NIV Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms T-Tube

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

About this study

Patients : 20 obese patients (defined by BMI over 30 kg/m2) ongoing for spontaneous breathing trial and clinically ready for immediate extubation will be enrolled after obtaining their consents. Material : An oeso-gastric double balloon catheter will be inserted in order to record oesophageal and gastric pressure and to calculate Work of Breathing and Pressure Time Product. Pulmonary Volumes will be recorded by a pneumotachograph. Functional Residual Capacity will be recorded thanks to the azote double dilution technique used by the Engström respiratory care station.Study Protocol : When physicians in charge of the patient decided that the patient is ready to be weaned and to have a SBT before extubation, the patient will be included in the study. Before extubation, patients will be placed under 5 different spontaneous breathing trials conditions in the same order : 7 cm H2O continuous positive airway pressure, T piece,7 cmH2O of pressure support, 0 cmH20 of pressure support and 7 cm H2O pressure support ventilation with 7 cmH20 of end expiratory pressure. Each trial will be performed fo 20 min. Between 2 spontaneous breathing trials, and before extubation, patient will receive a 10 minutes period of recovery to their respiratory baseline, defined by the respiratory settings before the spontaneous breathing trials.The last step, after extubation, will consist in recording the data after 15 minutes, when patient's breathing pattern appears calm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI > 30 kg/m2
Weaning procedure achieved, ongoing for extubation

Exclusion criteria

Contra indication for nasogastric catheter placement

Treatment and study plan

Spontaneous breathing trial

Procedure

5 spontaneous breathing trial will be tested by the patients in the same order :

7 cm H2O continuous positive airway pressure
T piece
7 cmH2O of pressure support
0 cmH20 of pressure support
7 cm H2O pressure support ventilation with 7 cmH20 of end expiratory pressure.

Primary outcomes

Work of breathing

Time frame: Duration of hospital stay: one day

Based upon the Campbell diagram, WOB will be calculated by integrating oesophageal pressure to tidal volume in time.

Secondary outcomes

Functional Residual Capacity

Time frame: Duration of hospital stay: one day

Lung recruitement will be evaluated by a bed side technique of FRC mesurement.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 12, 2012
Registry last updated: May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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