Neurally Adjusted Ventilatory Assist in Adults at Risk of Delayed Weaning From Mechanical Ventilation (RESTUS)
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|ClinicalTrials.gov Identifier: NCT01826890|
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation||Other: NAVA Technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomised Feasibility Study Examining Neurally-adjusted Ventilatory Assist (NAVA) in Patients at High Risk of Prolonged Ventilatory Failure During Recovery From Critical Illness.|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Experimental: NAVA technology
Following randomisation, a NAVA catheter will be introduced. The Electrical Activity of the Diaphragm (EAdi) will be viewed primarily to ensure a minimum level of diaphragm activation during the weaning phase. NAVA mode suitability/safety assessments will be conducted in all patients prior to the first initiation of the NAVA mode. The NAVA preview function on the Maquet Servo-i ventilators will be used to transfer from the previous mode to the NAVA mode, and the assessment will last for a maximum of 30 minutes. We are recommending the use of the NAVA ventilation mode during the weaning period. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.
Other: NAVA Technology
Use of NAVA technology: Diaphragmatic monitoring and NAVA ventilation mode
No Intervention: Standard Care
A NAVA catheter will be inserted following randomisation. The NAVA capabilities of the ventilator will be disabled. Patients will be ventilated according to local weaning protocol as per current standard care with either Pressure Support, Synchronised Intermittent Mandatory Ventilation, Volume Controlled Ventilation, Pressure Controlled Ventilation or Pressure Regulated Volume Controlled Ventilation. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.
- Protocol compliance [ Time Frame: 28 days ]Total time in the NAVA ventilation mode as a proportion of total time in an assisted spontaneous weaning ventilation mode within 28 days from randomisation.
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 ClinicalTrials.gov identifier (NCT number): NCT01826890
|King's College Hospital NHS Foundation Trust|
|London, United Kingdom, SE5 9RS|
|Principal Investigator:||Daniel J Hadfield||King's College Hospital NHS Trust|
|Study Chair:||Phillip A Hopkins||King's College Hopspital NHS Foundation Trust|
|Study Director:||Nicholas Hart||Guy's and St Thomas' NHS Foundation Trust|
|Study Director:||Gerrard F Rafferty||King's College Hospital NHS Trust|