The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients

NCT ID: NCT01944254

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

random to respiration

Cardiac output measurement at random to respiration

Group Type ACTIVE_COMPARATOR

Cardiac output measurement at random to respiration

Intervention Type PROCEDURE

Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD)

timed with expiration start

Cardiac output measurement synchronised at start of expiration.

Group Type EXPERIMENTAL

Cardiac output measurement synchronised at start of expiration

Intervention Type PROCEDURE

Cardiac output measurement obtained by PAC TD

timed to instructed exhalation

Cardiac output measurement timed to instructed exhalation. The patient will receive instructions to exhale slowly using a peak expiratory flow (PEF)-flute and the cardiac output measurement will be started (i.e bolus given) at the start of expiration.

Group Type EXPERIMENTAL

Cardiac output measurement timed to instructed exhalation

Intervention Type PROCEDURE

Cardiac output measurement obtained by PAC TD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardiac output measurement at random to respiration

Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD)

Intervention Type PROCEDURE

Cardiac output measurement synchronised at start of expiration

Cardiac output measurement obtained by PAC TD

Intervention Type PROCEDURE

Cardiac output measurement timed to instructed exhalation

Cardiac output measurement obtained by PAC TD

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Every patient that receives a pulmonary artery catheter (PAC) related to elective cardiac surgeries,
* informed and written consent to participation in the study in accordance with the Helsinki declaration
* hemodynamic stability

Exclusion Criteria

* Hemodynamical instability
* atrial fibrillation
* tricuspid insufficiency ≥ grade 2
* hemodialysis or other conditions where extra volume load can be negative,
* lack of ability to give a written consent to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Idar Kirkeby-Garstad, Dr.

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of circulation and medical imaging, NTNU

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Kjetsa E, Skjaervold NK, Skogvoll E, Kirkeby-Garstad I. Synchronizing thermodilution cardiac output measurements with spontaneous breathing does not improve precision. Acta Anaesthesiol Scand. 2016 Mar;60(3):354-9. doi: 10.1111/aas.12650. Epub 2015 Oct 26.

Reference Type RESULT
PMID: 26497869 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/409

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.