Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study. (PORPOISE-F)

February 20, 2025 updated by: Uppsala University

Physiological Monitoring in the OR; Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.

The aim of this study is to investigate if it is feasible to use a protocol in which avoiding oxygen desaturation in the brain during general anaesthesia can reduce the risk of negative postoperative behavior changes in children.

We will recruit children from at least five centres around the world for this feasibility study. Brain oxygenation will be monitored with Near Red Infrascopy (NIRS) which is like a saturation monitor placed on the forehead of the child during anesthesia. The anesthesia is done as per routine, but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain. We will also ask the parents to fill in a questionnaire with 27 questions about changes in their child's behavior 7 days after the operation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This project will investigate the potential effect of a protocol, targeted at counteracting cerebral desaturation during anaesthesia, with the aim of reducing negative post-operative changes in children. Negative post-operative changes (NPOBC) represent a surrogate outcome for neurocognitive damage associated with hemodynamic changes during general anaesthesia. This is a feasibility study that will examine anaesthesia team´s reactions to changes in (1) regional cerebral oxygen saturation (crSO2) (2) systemic hypotension or hypoxaemia, while also reporting any technical issues with data acquisition. We will also estimate the incidence of negative post-operative changes and explore any association with reduced crSO2 in our patient population compared with previous international data. Specifically, this feasibility study will provide data for the robust design and power analysis of a large-scale, randomised interventional trial in children undergoing anaesthesia, with the utilisation of a protocol targeting cerebral oxygen desaturation vs a control group of standard care with no access to crSO2 monitoring.

Methods At least 500 children of ages 6 months - 59 months will be recruited from at least 5 centers around the world. Besides routine monitoring, cerebral regional oxygen saturation (crsO2 will be monitored throughout the procedure.

Primary outcome The primary outcome is the feasibility of successful data collection of crO2, physiological and PHBQ data in a larger population over multiple international sites. This includes the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting will be determined.

Secondary outcomes:

  • The incidence of reduced crSO2 below baseline (more than 10%)
  • The area under the curve (AUC) of reduced crSO2 below baseline
  • The incidence of negative postoperative behaviour changes as determined by the PHBQ administered on day 7 & 30 following surgery.
  • A set of threshold values for and form of interventions to restore cr02 and/or mean arterial blood pressure (Actions may include any of the following interventions fluid bolus, vasoactive agents, Trendelenburg position, adjustment of anaesthetic dose, and change of ventilation settings)
  • The incidence of negative post-operative behavioural change and the extent of any association with the AUC of crSO2 below baseline

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children undergoing routine general anesthesia

Description

Inclusion Criteria:

  • Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.

Exclusion Criteria:

  • age < 6 months or ≥ 59 months

    • procedures requiring < 30 minutes of general anaesthesia
    • imaging procedures
    • procedures involving neurosurgery, oncology or burns
    • procedures involving significant pain lasting for more than 1 week on average (e.g. tonsillectomies, major orthopaedic surgery)
    • other procedures that limit access to the forehead
    • children that are on supplemental oxygen, are sedated or intubated at the time of inclusion
    • children with severe developmental delay
    • procedures with planned postoperative intensive care or hospital stay > 3 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children/Anesthesia
Diagnostic test: Near Red Infrascopy
Monitor of regional cerebral oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist
Time Frame: From the beginning of the anesthesia until 30 days postoperatively
The primary outcome is the feasibility
From the beginning of the anesthesia until 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CrsO2
Time Frame: From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
Cerebral regional oxygen saturation monitored with NIRS
From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
Negative postoperative behavior changes (NPOBC)
Time Frame: 7 to 30 days postoperatively
Negative postoperative behavior changes detected by asking the parents to report changes of behavior assessed with the Post Hospitalization Behavior Questionnaire (PHBQ) at day 7 and day 30 postop
7 to 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

University of Sao Paulo
Universitair Ziekenhuis Brussel
Istituto Giannina Gaslini
Uppsala County Council, Sweden
The University of Western Australia

Investigators

  • Principal Investigator: Peter Frykholm, M.D., Ph.D., Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PORPOISE Feasibility

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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