Evaluation of Lung Atelectasis During Apneic Oxygenation... | NCT03458091

Studies
Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery.

NCT03458091

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

THRIVE
Endotracheal intubation

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

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

Oct 2020

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

Jan 22, 2018Actual

Primary Completion Date

Oct 10, 2020Actual

Completion Date

Oct 10, 2020Actual

First Submitted Date

Jan 21, 2018

First Submission Date that Met QC Criteria

Mar 7, 2018

First Posted Date

Mar 8, 2018Actual

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 13, 2020

Last Update Posted Date

Oct 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Malin Jonsson Fagerlund, Senior Consultant, Associate Professor, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as lung atelectasis and inflammatory stress response before implementing it into clinical practice.

Detailed Description

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intubation	Active Comparator	The patients will be intubated and ventilated	Device: Endotracheal intubation
THRIVE	Experimental	The patients will be oxygenated during apnea using THRIVE	Device: THRIVE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THRIVE	Device	Oxygenation during apnea using transversal humidified oxygen	THRIVE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electrical impedans tomography	Changes in lung volumes	baseline, intraoperative, 2 hours after start of intervention

Secondary Outcomes

Measure	Description	Time Frame
Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure	Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure	max 30 minutes after start of intervention
Increase in arterial carbon dioxide during the apnea

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, >18 years old.
ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
Capable of understanding the study information and sign the written consent.

Exclusion Criteria:

ASA>2
NYHA >2
Pacemaker or ICD.
BMI >35
Pregnancy
Manifest cardiac failure or coronary disease
Severe gastrointestinal reflux.
Neuromuscular disorder

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malin Jonsson Fagerlund	Karolinska University Hospital and Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061485	Tobacco Use Cessation Devices
D007442	Intubation, Intratracheal

Ancestor Terms

ID	Term
D013812	Therapeutics
D058109	Airway Management
D007440	Intubation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided