Normoxic Challenges Utility to Evaluate Blood Loss

NCT03194581 | Terminated

• 1 other identifier: HEMOX
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Change in cerebral regional oxygen saturation

  Before and 3 minutes after normoxic challenges

Interventions

Cerebral oxygenation DEVICE

Evaluate cerebral oxygenation using normoxic challenges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients submitted to surgery with high risk of blood loss

You may qualify if:

• Elective surgery
• High risk of intraoperative blood loss
• General anaesthesia

You may not qualify if:

• Respiratory insufficiency
• Ischemic heart disease
• Stroke
• ASA classification \> 3
• Laparoscopic surgery

Sponsors & Collaborators

• Centro Hospitalar do Tâmega e Sousa: lead

Study Sites (1)

Centro Hospitalar Tâmega e Sousa

Penafiel, Porto District, Portugal

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 21, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

PT (1)