The Use of "O" Shaped- Endotracheal Tube During Intubatio... | NCT04520581

Studies
The Use of "O" Shaped- Endotracheal Tube During Intubation for General Anesthesia: Prospective Randomized Trial

NCT04520581

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 20, 2020Actual

Enrollment

238Estimated

Phase

Not Applicable

Conditions

Endotracheal Intubation

Interventions

group "O"

Countries

South Korea

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

Aug 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

Mar 24, 2020Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Mar 31, 2022Estimated

First Submitted Date

Aug 13, 2020

First Submission Date that Met QC Criteria

Aug 18, 2020

First Posted Date

Aug 20, 2020Actual

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

Aug 18, 2020

Last Update Posted Date

Aug 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yu-Kyung Bae, clinical professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

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 is prospective randomized trial study. "O" type tracheal intubation tube is anatomically consistent and will able to increase the success rate of first intubation without any other external help.

Detailed Description

This study is divided into two groups. : control vs. "O" shape endotracheal tube.

The investigator was studied 238 consecutive the American Society of Anesthesiologists' physical grades I and II adult patients scheduled to undergo general anesthesia requiring tracheal intubation for elective surgery. Exclusion criteria included a gross anatomical abnormality, before surgery of the head, neck and cervical spine, previously difficult tracheal intubation, loose teeth, or those requiring a rapid sequence or awake intubation, moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests. Anesthesia was induced with remifentanyl 3ng/kg, propopol 1-2 mg/kg or TIVA 2% fresopol 4ug/dL, remifentanyl 3ng/dL and rocuronium 0.8 mg/kg to facilitate tracheal intubation. Laryngoscopy was performed after the loss of the fourth twitch in the train-of-four in response to ulnar nerve stimulation. All laryngoscopies using a #4 Macintosh blade were performed with the patient placed in the sniffing position. Tracheal intubation was performed without assistance (ex. External laryngeal manipulation, Used stylet). A single experienced anesthesiologist, blinded to each group, performed all of the direct laryngoscopies and classified the laryngoscopic view according to the modified Cormack and Lehane grade, measured number of attempts, intubation time and blood pressure and heart rate before/ after intubation.

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

238Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Use in the shape of an endotracheal tube.
Group "O"	Experimental	Just before the induction of medicine is injected, the assistant makes endotracheal tube into "O" shape.	Other: group "O"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
group "O"	Other	Endotracheal tube was made "O" shape by assistants.	Group "O"

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First intubation success rate for each between two group	First laryngoscope tries was success using detection of end tidal CO2	Immediately after intubation

Secondary Outcomes

Measure	Description	Time Frame
First intubation time	After intubation, appearing end tidal CO2 at monitoring	within 60 seconds
Number of attempts	Number of intubation try

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consented to participate in the study
Aged 19 years or older
The American Society of Anesthesiologists' physical grades I and II
Undergo elective surgery under general anesthesia

Exclusion Criteria:

Do not agree to participate in research
Previously difficult tracheal intubation
Rapid induction of anesthesia
Previous c-spine disc or had surgery
Teeth are severely shaken or poor
Moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu-Kyung Bae	Contact	+821057054801		vansuri27@gmail.com

Overall Officials

Name	Affiliation	Role
Yu-Kyung Bae	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeongggi-do	13620	South Korea

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

Intervention Browse Module

MeSH Terms

ID	Term
C106365	O-antigen, Acinetobacter strain 90

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided