General Anesthetic Drug Adverse ReactionPORPOISE-FNCT06515080
Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
An observational study of General Anesthetic Drug Adverse Reaction, run by Uppsala University at 5 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- What is being tested?
- Near Red Infrascopy
- How many people
- 500 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 31 Mar 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing routine general anesthesia
Who may be able to join
- Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Australia1 site
Perth Children´s Hospital
Perth, Western Australia, 6009
Britta Regli von Ungern, M.D., Ph.D., +61420790101, Britta.Regli_vonUngern@health.wa.gov.au
Belgium1 site
Universitet Brussel
Brussels, 1050
Nadia Najafi, M.D., Ph.D., +32469160030, Nadia.Najafi@uzbrussel.be
Virgini, Virgini.VanBuggenhout@uzbrussel.be
Brazil1 site
University of Sao Paolo
São Paulo
Vinicius Quintao, +55 11 97127-3950, vinicius.quintao@hc.fm.us
Italy1 site
Istituto Gaslini
Genova, 16147
Nicola Disma, M.D., Ph.D., +39 338 2758043, nicoladisma@gaslini.org
Sweden1 site
Uppsala University Hospital
Uppsala, 75185
Peter Frykholm, M.D., Ph.D., +46186171240, peter.frykholm@uu.se
Peter Principal Investigator
About this study
Official title: 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.
Read the 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
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- Near Red Infrascopy
- Keywords
- regional oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Red InfrascopyDiagnostic test
Monitor of regional cerebral oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| Children/Anesthesia | Not described Receives: Diagnostic Test: Near Red Infrascopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting. Checklist
The primary outcome is the feasibility
Measured: From the beginning of the anesthesia until 30 days postoperatively
Secondary outcomes (2)
CrsO2
Cerebral regional oxygen saturation monitored with NIRS
Measured: From immediately before anesthesia induction until a few minutes after extubating up to 10 minutes
Negative postoperative behavior changes (NPOBC)
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
Measured: 7 to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start31 Mar 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for General Anesthetic Drug Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Western Australia, University of Sao Paulo, Universitair Ziekenhuis Brussel, Uppsala County Council, Sweden, Istituto Giannina Gaslini
- Responsible party
- Sponsor
- Investigators
- Peter Frykholm, M.D., Ph.D., Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515080
- Sponsor's protocol ID
- PORPOISE Feasibility
- Acronym
- PORPOISE-F
- Status last verified
- Feb 2025
- First submitted
- 17 Jul 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spaeder MC, Keller JM, Sawda CN, Surma VJ, Platter EN, White DN, Smith CJ, Harmon WG. Implementation of a Regional Oxygen Saturation Thought Algorithm and Association with Clinical Outcomes in Pediatric Patients Following Cardiac Surgery. Pediatr Cardiol. 2023 Apr;44(4):940-945. doi: 10.1007/s00246-022-03071-z. Epub 2022 Dec 13.
PubMed 36512036Gomez-Pesquera E, Poves-Alvarez R, Martinez-Rafael B, Liu P, Alvarez J, Lorenzo-Lopez M, Fierro I, Gomez-Sanchez E, Heredia-Rodriguez M, Gomez-Herreras JI, Tamayo E. Cerebral Oxygen Saturation and Negative Postoperative Behavioral Changes in Pediatric Surgery: A Prospective Observational Study. J Pediatr. 2019 May;208:207-213.e1. doi: 10.1016/j.jpeds.2018.12.047. Epub 2019 Feb 6.
PubMed 30737038McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
PubMed 30782342Jevtovic-Todorovic V, Useinovic N. Early exposure to general anaesthesia and increasing trends in developmental behavioural impairments: is there a link? Br J Anaesth. 2023 Aug;131(2):208-211. doi: 10.1016/j.bja.2023.04.005. Epub 2023 May 10.
PubMed 37173202
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Monitoring in the OR; Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.
- ClinicalTrials.gov ID
- NCT06515080
- Acronym / sponsor ID
- PORPOISE-F / PORPOISE Feasibility
- Conditions
- General Anesthetic Drug Adverse Reaction
- Keywords
- regional oxygen saturation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The University of Western Australia, University of Sao Paulo, Universitair Ziekenhuis Brussel, Uppsala County Council, Sweden, Istituto Giannina Gaslini
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children/Anesthesia | – | Diagnostic Test: Near Red Infrascopy |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing routine general anesthesia
Key inclusion criteria (1 listed)
- Children scheduled for both elective and non-elective, non-cardiac surgical procedures under general anaesthesia.
Key exclusion criteria (9 listed)
- age \< 6 months or ≥ 59 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Red InfrascopyMonitor of regional cerebral oxygen saturation | Diagnostic test | Children/Anesthesia |
Primary outcome
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
2 secondary outcomes
CrsO2
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 36512036Spaeder MC, Keller JM, Sawda CN, Surma VJ, Platter EN, White DN, Smith CJ, Harmon WG. Implementation of a Regional Oxygen Saturation Thought Algorithm and Association with Clinical Outcomes in Pediatric Patients Following Cardiac Surgery. Pediatr Cardiol. 2023 Apr;44(4):940-945. doi: 10.1007/s00246-022-03071-z. Epub 2022 Dec 13.
- Background: PubMed 30737038Gomez-Pesquera E, Poves-Alvarez R, Martinez-Rafael B, Liu P, Alvarez J, Lorenzo-Lopez M, Fierro I, Gomez-Sanchez E, Heredia-Rodriguez M, Gomez-Herreras JI, Tamayo E. Cerebral Oxygen Saturation and Negative Postoperative Behavioral Changes in Pediatric Surgery: A Prospective Observational Study. J Pediatr. 2019 May;208:207-213.e1. doi: 10.1016/j.jpeds.2018.12.047. Epub 2019 Feb 6.
- Background: PubMed 30782342McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
- Background: PubMed 37173202Jevtovic-Todorovic V, Useinovic N. Early exposure to general anaesthesia and increasing trends in developmental behavioural impairments: is there a link? Br J Anaesth. 2023 Aug;131(2):208-211. doi: 10.1016/j.bja.2023.04.005. Epub 2023 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Frykholm, M.D., Ph.D. principal investigator
Uppsala University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthetic Drug Adverse Reaction, run by Uppsala University at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Belgium, Brazil, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Frykholm, M.D., Ph.D. (+46186171240, peter.frykholm@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515080, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.