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
Secondary identifying numbers N/A
Submission date
04/01/2007
Registration date
14/02/2007
Last edited
14/02/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

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

Study information

Study designInterventional, single centre, non-randomised or blinded trial
Primary study designInterventional
Secondary study designSingle-centre
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesThe 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) studiedAnaesthetised patients
InterventionWhile 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hydroxyethyl Starch (Voluven®)
Primary outcome measureCoherence between the magnitude of the PEEP-induced alterations of SV and the patients fluid responsiveness.
Secondary outcome measures1. 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
Overall study start date08/01/2007
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteriaPatients admitted to Aalborg Hospital for elective surgery of the spinal column.
Key exclusion criteria1. 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 enrolment08/01/2007
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Denmark

Study participating centre

Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg
9000
Denmark

Sponsor information

Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)
Hospital/treatment centre

Soendre Skovvej 3, 2.
Aalborg
9000
Denmark

Phone +45 993 28057
Email ndn@rn.dk
Website http://www.an.rn.dk
ROR logo "ROR" https://ror.org/003gkfx86

Funders

Funder type

Hospital/treatment centre

Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)

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