Clinical Trial: Neurally Adjusted Ventilatory Assist in Adults at Risk of Delayed Weaning From Mechanical Ventilation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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.
Brief Summary: Many patients admitted to intensive care have heart or lung problems. Patients with these conditions often require longer durations of support from breathing machines. Survival and long-term recovery are improved if the investigators can remove the breathing support quickly. In this study, the investigators will focus on patients with severe lung or heart disease to examine whether a particular type of breathing machine (NAVA ventilator) will allow us to remove breathing support more quickly and with less need for sedative medications, when compared to current practice.
Detailed Summary:
In this study, we will compare the use of Neurally Adjusted Ventilatory Assist technology (the NAVA ventilation mode and the monitoring capabilities) against standard care in patients who are at risk of prolonged periods of mechanical ventilation.
Study aim
To inform the design of a definitive randomised controlled trial (RCT) by undertaking feasibility testing, evaluation of the proposed NAVA intervention and evaluation of the proposed outcomes.
Feasibility outcomes
- Number of eligible patients
- Assessment of screening and recruitment methods
- The willingness of clinicians to allow recruitment
- The willingness of participants to be randomised
- Assessment of the randomisation process
- Staff attitudes and training needs
- Protocol compliance (barriers to the use of NAVA ventilation)
Intended primary outcomes of the main study
*Ventilator-free days (day 28)
There are a number of secondary outcomes that include:
- Total sedation / hypnotic / analgesic dose
- Ventilator free days (day 90)
- Duration of invasive mechanical ventilation (MV)
- Duration of MV (including Non-invasive ventilation (NIV))
- Duration of post extubation NIV <
- Ventilator Free Days [ Time Frame: 28 days ]
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.
Unassisted breathing:
- 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.
- Sedation / hypnotic / analgesic dose [ Time Frame: 28 days from randomisation ]Dose per kg of all sedation, analgesia and hypnotic medication. Change in requirement will be correlated with the mode of ventilation.
Sponsor: King's College Hospital NHS Trust
Current Primary Outcome: Protocol compliance [ Time Frame: 28 days ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: King's College Hospital NHS Trust
Dates:
Date Received: April 4, 2013
Date Started: May 2013
Date Completion: January 2018
Last Updated: December 7, 2016
Last Verified: April 2013
