Automatic weaning with adaptive support ventilation (ASV): effect on nurse workload and duration of spontaneous ventilation until extubation

ISRCTN	ISRCTN65935865
DOI	https://doi.org/10.1186/ISRCTN65935865
Protocol serial number	NTR154
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr M J Schultz
Scientific

Department of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	m.j.schultz@amc.uva.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	We hypothesise that: 1. Adaptive support ventilation (ASV) reduces the number of nurse-ventilator interactions in non-fast track cardiac surgery patients 2. ASV lengthens the period of spontaneous breathing, while shortening the total respiratory weaning time
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Mechanical ventilation
Intervention	Patients will be either ventilated in a standard fashion (i.e., pressure controlled mechanical ventilation or pressure support mechanical ventilation) or by ASV.
Intervention type	Other
Primary outcome measure(s)	1. Number of arterial blood gas (ABG) analyses 2. Number of audible alarms 3. Number of manual changes in the ventilator settings, including: 3.1. Switches from PC to PS (only in the control group) 3.2. Changes in minute ventilation (only in the ASV group) 3.3. Lowering of PS-level (only in the control group) 4. Duration of period of spontaneous mechanical ventilation 5. Duration of total period of tracheal intubation
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/10/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	128
Key inclusion criteria	1. Planned uneventful cardiac surgery i.e. coronary artery bypass graft (CABG) 2. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out
Key exclusion criteria	1. History of pulmonary disease 2. History of pulmonary surgery 3. Valve surgery 4. Arrival at the IC-unit with IABP or inotropes at a more then usual rate (in ml per hour: dopamine (4), norepinephrine (4), dobutamin (4) or epinephrine [any rate])
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2006

Department of Intensive Care

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan