Optimized Oxygen Delivery During General Anesthesia in Ne... | NCT02698020

Studies
Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

NCT02698020

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Oct 15, 2018Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Oxygen Toxicity
Oxidative Stress

Interventions

Room-air

Countries

Sweden

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Jul 30, 2018Actual

Completion Date

Oct 10, 2018Actual

First Submitted Date

Feb 25, 2016

First Submission Date that Met QC Criteria

Feb 25, 2016

First Posted Date

Mar 3, 2016Estimated

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

Oct 10, 2018

Last Update Posted Date

Oct 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

Detailed Description

Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	High level of supplemental inspired oxygen
Room-air	Experimental	Supplemental oxygen only provided if oxygen saturation below target	Procedure: Room-air

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Room-air	Procedure	Provision of room-air	Room-air

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcutaneous and blood-gas pO2	Area under curve (AUC) and absolute values of pO2	30 min

Secondary Outcomes

Measure	Description	Time Frame
Cerebral Oximetry	AUC of O2 saturation	30 min
Atelectasis	Reduced lung compliance as a measure of atelectasis formation	30 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Newborn less than 44 weeks postconceptional age
No pulmonary disease, no oxygen requirement, or assisted ventilation
No genetic syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

4 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan Agren, MD, PhD	Department of Women's and Children's Health, Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University Hospital, Pediatric anesthesia Unit		Uppsala		75185	Sweden

Type	Date	Date Unknown
Release	Nov 1, 2022
Reset	Sep 11, 2023
Release	Mar 27, 2025
Reset	Apr 15, 2025

Submission Tracking

Estimated Results First Submitted Date

Nov 1, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 1, 2022			Sep 11, 2023
Mar 27, 2025

Condition Browse Module

MeSH Terms

ID	Term
D018496	Hyperoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided