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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06515080




Registration number
NCT06515080
Ethics application status
Date submitted
17/07/2024
Date registered
23/07/2024

Titles & IDs
Public title
Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Scientific title
Physiological Monitoring in the OR; Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
Secondary ID [1] 0 0
PORPOISE Feasibility
Universal Trial Number (UTN)
Trial acronym
PORPOISE-F
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Anesthetic Drug Adverse Reaction 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Near Red Infrascopy

Children/Anesthesia -


Diagnosis / Prognosis: Near Red Infrascopy
Monitor of regional cerebral oxygen saturation
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist
Timepoint [1] 0 0
From the beginning of the anesthesia until 30 days postoperatively
Secondary outcome [1] 0 0
CrsO2
Timepoint [1] 0 0
From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
Secondary outcome [2] 0 0
Negative postoperative behavior changes (NPOBC)
Timepoint [2] 0 0
7 to 30 days postoperatively

Eligibility
Key inclusion criteria
* Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Minimum age
6 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Perth Children´s Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paolo
Country [2] 0 0
Sweden
State/province [2] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Other
Name
Uppsala University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sao Paulo
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Universitair Ziekenhuis Brussel
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Frykholm, M.D., Ph.D.
Address 0 0
Uppsala University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter Frykholm, M.D., Ph.D.
Address 0 0
Country 0 0
Phone 0 0
+46186171240
Fax 0 0
Email 0 0
peter.frykholm@uu.se
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06515080