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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01616901
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : May 31, 2013
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Respiratory Failure PSV 7cmH2O PEEP 7cmH2O PSV 7 cmH2O PEEP 0 cmH20 CPAP 7 cmH2O PSV 0 cmH20 PEEP 0 cmH2O T-Tube Post-extubation in Spontaneous Breathing and/or in NIV Procedure: Spontaneous breathing trial Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: Spontaneous breathing trial Procedure: Spontaneous breathing trial

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 Outcome Measures :
  1. 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 Outcome Measures :
  1. Functional Residual Capacity [ Time Frame: Duration of hospital stay: one day ]
    Lung recruitement will be evaluated by a bed side technique of FRC mesurement.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Contra indication for nasogastric catheter placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01616901

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Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier Identifier: NCT01616901     History of Changes
Other Study ID Numbers: 8923
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: June 2012
Keywords provided by University Hospital, Montpellier:
Intensive Care
Respiratory weaning
Spontaneous Breathing trial
Work of breathing
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes