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Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm (OWED)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02539732
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : April 4, 2019
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
Several types of spontaneous breathing trials (SBTs) have been proposed to evaluate when a patient is ready to be weaned from the ventilator based on breathing pattern measurements. The T-piece technique allows clinicians to calculate breathing patterns accurately but many prefer to use minimal levels of assistance, which unfortunately modifies breathing pattern. The interest of Neurally Adjusted Ventilatory Assist (NAVA) is that tidal volume (Vt) supposedly represents what the patient really wants: without disconnecting the patient from the ventilator, it may be possible to determine what is the real need and whether the patient is able to maintain Vt without support. The aims of the study are as follows: to test whether the changes in Vt after the removal of a standardized level of NAVA assistance (ΔVt) can predict weaning outcome; to compare the proposed titration of effort in NAVA (occlusion) with Patient-Ventilator Breath Contribution (PVBC) and titration using the Pmusc/Eadi index (PEI) relating the pressure generated by the respiratory muscles (muscular pressure; Pmusc) to the electrical activity of the diaphragm (EAdi); to assess the effect of PEEP on the change in Vt; and to evaluate EAdi after extubation. Patients ventilated for at least 24 hours who are ready to undergo an SBT will be included. Patients younger than 18 years of age and/or who have a contraindication to NAVA catheter insertion and/or surgical patients expected to be extubated within 12 hours will be excluded. After a baseline inclusion period with the pre-enrollment mode of ventilation, the standardized NAVA level will be applied for 20 minutes, during which both Patient-Ventilator Breath Contribution (PVBC) and PEI will be calculated. After the NAVA trial, a period of Continuous Positive Airway Pressure (CPAP) 5 (2-3 minutes) followed by a period of CPAP 0 (2-3 minutes) (both with NAVA gain 0) will be performed in order to record the difference with Vt during standardized NAVA (ΔVt). At the end of this period, the patient will be switched back to the baseline settings for 30 minutes-3 hours. After this period, the patient will perform an SBT with CPAP 0 or CPAP 5 for 1 hour. At the end of the SBT, the attending physician will decide whether or not to extubate the patient according to standard criteria and blinded to the ΔVt results. Ultimately, patients will be classified as "success" or "failure" and the ΔVt will be compared between these two groups.

Condition or disease
Respiratory Insufficiency

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Primary Outcome Measures :
  1. Change in tidal volume after removing a standardized level of NAVA assistance. [ Time Frame: Up to 3 hours ]

Secondary Outcome Measures :
  1. Comparison of Pmusc estimated by an occlusion technique, PVBC, and PEI. [ Time Frame: Up to 3 hours ]
  2. Change in tidal volume from PEEP of 5 centimeters of water (cmH2O) to zero PEEP. [ Time Frame: Up to 3 hours ]
  3. Change in EAdi during NAVA mode, CPAP, and after extubation. [ Time Frame: Up to 7 days ]

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
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated Intensive Care Unit patients who are ready to undergo a Spontaneous Breathing Trial.

Inclusion Criteria:

  • Patients ready to undergo an SBT based on the decision of the clinical team.
  • Patients ventilated for at least 24 hours

Exclusion Criteria:

  • Patients younger than 18 years-old
  • Contraindication to NAVA catheter insertion (e.g., recent surgery, bleeding)
  • Central Neurological disorder (hemorrhage, tumor, massive stroke, etc.) heavily influencing breathing pattern
  • Surgical patients expected to be extubated within 12 hours.

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): NCT02539732

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Contact: Laurent J. Brochard, MD 416-864-6060 ext 5686

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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Laurent J. Brochard, MD    416-864-6060 ext 5686   
Centre Hospitalier Universitaire Angers Not yet recruiting
Angers, France, 49933
Contact: Alain Mercat, MD    +33241353815   
Contact: Francois Beloncle, MD    +33241353815   
Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia Recruiting
Foggia, Italy, 71122
Contact: Gilda Cinnella, MD    +39 0881 73 23 07   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT02539732    
Other Study ID Numbers: REB# 15-214
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Keywords provided by St. Michael's Hospital, Toronto:
Spontaneous breathing trial
Neurally-adjusted ventilator assist
Electrical activity of the diaphragm
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases