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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01616901
First received: June 4, 2012
Last updated: May 30, 2013
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 :

  • 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.

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contra indication for nasogastric catheter placement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616901

Locations
France
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
  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
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014