Quality of Preoxygenation in Emergency Surgery | NCT04070404

Studies
Quality of Preoxygenation in Emergency Surgery

NCT04070404

Sponsor

Vilnius University

Status

Unknown status

Last Update Posted

Oct 9, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Preoxygenation
Anaesthesia
Emergencies
Surgery

Interventions

Not provided

Countries

Lithuania

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

May 1, 2021Estimated

Completion Date

May 1, 2022Estimated

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

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 8, 2020

Last Update Posted Date

Oct 9, 2020Actual

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

Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.

The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.

Detailed Description

Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.

Parameters analysed:

Preoperative: medical history, physical examination, laboratory findings, anthropometric data
Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficient preoxygenation in preset time	End-tidal oxygen concentration values	300 seconds

Secondary Outcomes

Measure	Description	Time Frame
Factors influencing preoxygenation quality	Medical history, physical status, lab findings, preoxygenation equipment and method	300 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed consent
patient going for emergency surgery under general anaesthesia
age > 18 years

Exclusion Criteria:

informed consent refusal
noneligible for preoxygenation before general anaesthesia

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

All eligible patients undergoing general anaesthesia for emergency surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Egle Kontrimaviciute, Assoc Professor	Contact	+37052365264		egle.kontrimaviciute@santa.lt
Ruta Januleviciene, MD	Contact	+37052365264		ruta.januleviciene2@santa.lt

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vilnius University Hospital Santaros Clinics	Recruiting	Vilnius			Lithuania

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided