Normoxic Challenges Utility to Evaluate Blood Loss | NCT03194581

Studies
Normoxic Challenges Utility to Evaluate Blood Loss

NCT03194581

Sponsor

Centro Hospitalar do Tâmega e Sousa

Status

Terminated

Last Update Posted

Mar 22, 2022Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Hemorrhage

Interventions

Cerebral oxygenation

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Profissional reasons, not related with the study

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Sep 30, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Jun 12, 2017

First Submission Date that Met QC Criteria

Jun 19, 2017

First Posted Date

Jun 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cerebral oxygenation	Device	Evaluate cerebral oxygenation using normoxic challenges

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cerebral regional oxygen saturation		Before and 3 minutes after normoxic challenges

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective surgery
High risk of intraoperative blood loss
General anaesthesia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients submitted to surgery with high risk of blood loss

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Hospitalar Tâmega e Sousa		Penafiel	Porto District		Portugal

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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