Condition category
Not Applicable
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
12/05/2016
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 E.J. Lieshout, van

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Intensive Care and Mobile Intensive Care Unit (MICU)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5665043
e.j.vanlieshout@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

IC-physician versus qualified IC-nurse-based interhospital critical care transport (IQ-transport) study

Acronym

IQ-transport study

Study hypothesis

Interhospital transport of IC-patients can be escorted solely by a registered IC-nurse.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intensive Care (IC) patients

Intervention

Study strategies:
1. Transport will be performed by a physician-based team: an IC-trained physician will accompany a registered IC-nurse
2. Transport will be performed solely by a registered IC-nurse. In this strategy, an IC-physician is physically present during inter-hospital transport; however, the physician does not play any role in the treatment of patient until a formal request is made by the IC-nurse.
In both strategies the ambulance crew is present.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of critical events defined as:
1. Related to intensive care (lead disconnections, loss of battery power or any other technical equipment failure, airway loss requiring airway manipulation or reintubation, loss of any intravascular device, dislodgment of any thoracostomy tube, Foley catheter, or surgical drain)
2. Clinical deteriorations related to critical illness (death, decrease in arterial saturation of >10% for >10 min, undesired rise or fall in arterial blood pressure [systolic, diastolic or mean, defined as >20 mmHg from baseline for >10 min], hemorrhage or blood loss estimated to be >250 ml, new cardiac arrhythmias with associated hemodynamic deterioration or are generally accepted as requiring urgent therapy [occasional premature ventricular or atrial contractions were not considered significant], temperature fall below 36 degrees Celsius)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2006

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive IC-patients (>18 years of age) transported by the Mobile Intensive Care Unit, Academic Medical Center, University of Amsterdam.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

IC-patients considered to be too instable to be transported without a physician as team member - one or more of the following criteria:
1. Pa02/Fi02 <100 with PEEP >15
2. Mean arterial pressure <60 mmHg despite adequate fluid therapy and inotropics (noradrenalin >0.35 kg/microg/min, dopamine >15 kg/microg/min)
3. Episode of resuscitation (chest compression or cardiac defibrillation) in 24 hours before interhospital transport

Recruitment start date

01/02/2006

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC), Mobile Intensive Care Unit (The Netherlands)

Sponsor details

Postbus 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Academic Medical Center (AMC)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27166622

Publication citations

Additional files

Editorial Notes

12/05/2016: Publication reference added.