Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT03143179

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The immediate period after spinal cord injury (SCI) is one of the only opportunities that clinicians and care-givers have to make a real difference to patient outcomes. One of the main aims during this period is to preserve blood flow and oxygen delivery to the spinal cord to prevent any further damage from occurring after the injury. The heart acts as the major pump for blood to be pumped to the spinal cord and the body. It has been shown in small animal models and in humans with long-standing SCI that the ability of the heart to pump blood after injury is compromised, which may in turn reduce the amount of blood and oxygen delivered to the injured cord. It is unclear how quickly these changes occur in the heart following SCI and how best to manage heart function such that blood flow and oxygen delivery can be optimized. In the present study, the investigators will examine how the heart functions immediately after SCI. The findings from this study are expected to provide new information that could help clinicians improve the management of people who have just suffered a SCI.

Conditions

Spinal Cord Injuries

Study ID

NCT03143179

Start date

May 16, 2018

Status verified date

Aug, 2020

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Oct 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female aged 18-60yrs
  • Acute traumatic SCI at T2 or above within the last 72 hours
  • Complete (American Spinal Injuries Association Impairment Scale (AIS) A) or incomplete (AIS B) initial designation
  • Requires insertion of central venous catheter and arterial catheter as part of standard clinical care
  • Able to communicate in English and provide informed consent
  • in sinus rhythm.

Exclusion Criteria:

  • History and/or symptoms of cardiovascular disease or cardiopulmonary problems/disease, including controlled/uncontrolled hypertension
  • Historical or current nasal injury (incl. cosmetic surgery)
  • Nasal polyps
  • Concurrent facial trauma
  • Traumatic brain injury
  • Concurrent intra-aortic balloon pump
  • Carcinoma/major surgery of the pharynx, larynx or esophagus
  • Aneurysms of the thoracic aorta
  • Tissue necrosis of the esophagus or nasal passage
  • Any other medical condition that in the investigator's opinion would render the study procedures dangerous.

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • daily resting ejection fraction [ Time Frame: up to 3 days ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, Canada

Contacts

Leilani Reichl

Leilani.Reichl@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

Aug 24, 2020

Last verified

Aug, 2020

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 British Columbia on 2020-08-24.