Do positive end-expiratory pressure-induced changes in cardiac output indicate fluid responsiveness in anaesthetised patients?

ISRCTN	ISRCTN07173607
DOI	https://doi.org/10.1186/ISRCTN07173607
Protocol serial number	N/A
Sponsor	Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)
Funder	Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)

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

Prof Anders Larsson
Scientific

Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg Hospital
Hobrovej 18-22
Aalborg
9000
Denmark

Email	an.larsson@nja.dk

Primary study design	Interventional
Study design	Interventional, single centre, non-randomised or blinded trial
Secondary study design	Single-centre
Scientific title
Study objectives	The magnitude of changes in cardiac output induced by alternating Positive End-Expiratory Pressures (PEEP) predict fluid responsiveness in anaesthetised patients.
Ethics approval(s)	Approved by The Scientific Ethical Committee of North Denmark Region on 13th December 2006.
Health condition(s) or problem(s) studied	Anaesthetised patients
Intervention	While monitoring cardiac Stroke Volume (SV) we alternate the Positive End-Expiratory Pressure (PEEP) by 10 cm H2O. If the PEEP-alteration results in a change in SV of more than 5 mL we hypothesise that the patient is fluid responsive. Subsequently we measure SV before and after loading the patient with 250 mL of Hydroxyethyl Starch (Voluven®) to obtain a measure of the patients fluid responsiveness.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Hydroxyethyl Starch (Voluven®)
Primary outcome measure(s)	Coherence between the magnitude of the PEEP-induced alterations of SV and the patients fluid responsiveness.
Key secondary outcome measure(s)	1. Coherence between the magnitude of PEEP-induced alterations of pulse pressure and the patients fluid responsiveness 2. Coherence between the magnitude of PEEP-induced alterations of heart rate and the patients fluid responsiveness
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key inclusion criteria	Patients admitted to Aalborg Hospital for elective surgery of the spinal column.
Key exclusion criteria	1. Severe right-sided cardiac insufficiency 2. Severe anaemia 3. Pregnancy 4. Children (age less than 18 years) 5. Patients without esophageal doppler monitoring of cardiac output 6. Patients who experience severe complications during anaesthesia
Date of first enrolment	08/01/2007
Date of final enrolment	01/09/2007

Anaesthesia and Intensive Care Medicine of North Denmark Region

Aalborg
9000
Denmark

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