NCT05985525

Brief Summary

Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 27, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

August 2, 2023

Last Update Submit

August 19, 2025

Conditions

Keywords

Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Recruitment

    Recruitment of two patients per month from each study site

    30 days

Secondary Outcomes (3)

  • protocol adherence

    14 days

  • NIRS and vital sign data quality

    14 days

  • Optimal Map (MAPopt) derivation

    14 days

Other Outcomes (2)

  • ICU mortality

    30 days

  • Hospital mortality

    100 days

Study Arms (1)

Observational

All patients

Device: Skeletal muscle and cerebral NIRS (research device)

Interventions

NIRS applied on skeletal muscle and brain on days 1, 3, and 8 of ICU admission. Monitoring applied for up to 24hrs on each day.

Also known as: PortaMon (Artinis Inc, Netherlands), PortaLite (Artinis Inc, Netherlands)
Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults admitted to the ICU receiving invasive mechanical ventilation

You may qualify if:

  • Admitted to ICU
  • Receiving invasive mechanical ventilation

You may not qualify if:

  • Body Mass Index \>40
  • More than 24 hours has elapsed since ICU admission
  • Death is deemed to be imminent and inevitable during the next 24 hours
  • Known allergy to the textile components of the device
  • Significant clinical jaundice, ecchymosis
  • COVID positive microbiological result
  • The treating clinician believes that participation in the domain would not be in the best interests of the patient
  • Consent declined from patient or authorized third party

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

SepsisShockCritical Illness

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Asher Mendelson, MD, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asher Mendelson, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

May 27, 2022

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations