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

NCT01616901 | Completed DMC

• 1 other identifier: 8923
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Work of breathing

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

  Duration of hospital stay: one day

Secondary Outcomes (1)

• Functional Residual Capacity

  Duration of hospital stay: one day

Study Arms (1)

Spontaneous breathing trial

EXPERIMENTAL

Procedure: Spontaneous breathing trial

Interventions

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.

Spontaneous breathing trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contra indication for nasogastric catheter placement

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

Location

Related Publications (1)

• 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.

  PMID: 27784322 DERIVED

MeSH Terms

Conditions

Obesity; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 12, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 31, 2013

Record last verified: 2012-06

Locations

FR (1)