Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient |
- Work of breathing [ Time Frame: Duration of hospital stay: one day ] [ Designated as safety issue: No ]Based upon the Campbell diagram, WOB will be calculated by integrating oesophageal pressure to tidal volume in time.
- Functional Residual Capacity [ Time Frame: Duration of hospital stay: one day ] [ Designated as safety issue: No ]Lung recruitement will be evaluated by a bed side technique of FRC mesurement.
| Enrollment: | 31 |
| Study Start Date: | April 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Spontaneous breathing trial |
Procedure: Spontaneous breathing trial
5 spontaneous breathing trial will be tested by the patients in the same order :
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI > 30 kg/m2
- Weaning procedure achieved, ongoing for extubation
Exclusion Criteria:
- Contra indication for nasogastric catheter placement
Contacts and Locations More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01616901 History of Changes |
| Other Study ID Numbers: | 8923 |
| Study First Received: | June 4, 2012 |
| Last Updated: | May 30, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Montpellier:
|
Obese Intensive Care Respiratory weaning Spontaneous Breathing trial Work of breathing |
Additional relevant MeSH terms:
|
Respiratory Aspiration Obesity Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Overnutrition Nutrition Disorders Overweight Body Weight |
ClinicalTrials.gov processed this record on June 17, 2013