Recruiting

Microvascular Monitoring

Sponsor:

University of Manitoba

Code:

NCT05985525

Conditions

Sepsis

Shock

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Skeletal muscle and cerebral NIRS (research device)

Study Details

Brief summary:

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

Conditions

Sepsis

Shock

Critical Illness

Study ID

NCT05985525

Start date

May 27, 2022

Status verified date

Aug, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted to ICU
  • Receiving invasive mechanical ventilation

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

All patients

Interventions

Skeletal muscle and cerebral NIRS (research device)

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.

Primary outcome measure

  • Recruitment [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Asher Mendelson, MD, PhD

2047871634asher.mendelson@umanitoba.ca

Locations

Health Sciences Centre Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Asher Mendelson, MD PhD

2047871634asher.mendelson@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • Near-Infrared Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-08-24.