Neurally Adjusted Ventilatory Assist in Adults at Risk of Delayed Weaning From Mechanical Ventilation (RESTUS)
Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation
Other: NAVA Technology
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.|
- Ventilator Free Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
The number of calendar days from initiating unassisted breathing to day 28 after randomisation, assuming survival for at least 48 hours after initiating unassisted breathing and continued unassisted breathing to day 28.
If unassisted breathing is achieved twice prior to day 28, VFDs will be counted from the end of the last period to day 28. Short periods of assisted breathing (<24 hours) will not count against the VFD calculation. Where assisted breathing occurs at day 27 or death occurs prior to day 28, without 48 consecutive hours of unassisted breathing following termination of assisted breathing, VFDs will be 0.
- Extubated with supplemental oxygen or room air
- Open T-tube breathing
- Tracheostomy mask breathing
- CPAP less than or equal to 5 cm H20 without pressure support
Patients receiving pressure support via non-invasive ventilation will be defined as receiving assisted ventilation, except where CPAP/BIPAP is used at night.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826890
|Contact: Daniel J Hadfield||0044 (0) firstname.lastname@example.org|
|Contact: Philip A Hopkins||0044 (0) 20 3299 email@example.com|
|King's College Hospital NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE5 9RS|
|Contact: Daniel J Hadfield 020 3299 2080 firstname.lastname@example.org|
|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|