Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M J Schultz

ORCID ID

Contact details

Department of Intensive Care
Academic Medical Centre
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.j.schultz@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR154

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant 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])

Recruitment start date

01/10/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Intensive Care
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes