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
Secondary identifying numbers NTR154
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
03/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
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

Contact information

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

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWe 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) studiedMechanical ventilation
InterventionPatients will be either ventilated in a standard fashion (i.e., pressure controlled mechanical ventilation or pressure support mechanical ventilation) or by ASV.
Intervention typeOther
Primary outcome measure1. 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
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/10/2005
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants128
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2005
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Department of Intensive Care
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan