NCT03307889

Brief Summary

Observational study in which pulse transit time (PTT) as a method and the device to register this data is compared with arterial blood pressure. The population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

October 6, 2017

Last Update Submit

October 16, 2021

Conditions

Blood PressurePerioperative/Postoperative Complications

Keywords

perioperative monitoring

Outcome Measures

Primary Outcomes (1)

  • Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.

    Difference in mmHg between blood pressure calculated by PTT and arterial blood pressure. A video will record the measurement session in order to determine any action correlating to changes in blood pressure. A second use of the video is to determine what other action taken around the patient causing noise or confounding measurements,

    45 minutes- 120 minutes

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric and adult patients in anesthesia or intensive care.

You may qualify if:

  • Arterial line planned or existing

You may not qualify if:

  • suspected major perioperative hemodynamic variation.
  • non existing consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademiska Sjukhuset

Uppsala, Upp, 75385, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Hultström, Ass Prof

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 12, 2017

Study Start

August 20, 2017

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Supporting information will be made available after publication.
Access Criteria
Data and supporting information will be made available to interested researchers upon request.

Locations

SE(1)