Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient
Primary Purpose
Obesity, Respiratory Failure, PSV 7cmH2O PEEP 7cmH2O
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spontaneous breathing trial
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity focused on measuring Obese, Intensive Care, Respiratory weaning, Spontaneous Breathing trial, Work of breathing
Eligibility Criteria
Inclusion Criteria:
- BMI > 30 kg/m2
- Weaning procedure achieved, ongoing for extubation
Exclusion Criteria:
- Contra indication for nasogastric catheter placement
Sites / Locations
- Department of Anesthesiology & Critical Care, St Eloi University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spontaneous breathing trial
Arm Description
Outcomes
Primary Outcome Measures
Work of breathing
Based upon the Campbell diagram, WOB will be calculated by integrating oesophageal pressure to tidal volume in time.
Secondary Outcome Measures
Functional Residual Capacity
Lung recruitement will be evaluated by a bed side technique of FRC mesurement.
Full Information
NCT ID
NCT01616901
First Posted
June 4, 2012
Last Updated
May 30, 2013
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01616901
Brief Title
Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient
Official Title
Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Obese, Intensive Care, Respiratory weaning, Spontaneous Breathing trial, Work of breathing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spontaneous breathing trial
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Spontaneous breathing trial
Intervention Description
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 Measure Information:
Title
Work of breathing
Description
Based upon the Campbell diagram, WOB will be calculated by integrating oesophageal pressure to tidal volume in time.
Time Frame
Duration of hospital stay: one day
Secondary Outcome Measure Information:
Title
Functional Residual Capacity
Description
Lung recruitement will be evaluated by a bed side technique of FRC mesurement.
Time Frame
Duration of hospital stay: one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 30 kg/m2
Weaning procedure achieved, ongoing for extubation
Exclusion Criteria:
Contra indication for nasogastric catheter placement
Facility Information:
Facility Name
Department of Anesthesiology & Critical Care, St Eloi University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27784322
Citation
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.
Results Reference
derived
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Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient
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