The Depth of Endotracheal Tube Insertion | NCT03878797

Studies
The Depth of Endotracheal Tube Insertion

NCT03878797

Sponsor

Gao Mei

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Endotracheal Intubation

Interventions

Not provided

Countries

China

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

Jan 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

May 20, 2019Actual

Primary Completion Date

Dec 26, 2019Actual

Completion Date

Dec 26, 2019Actual

First Submitted Date

Mar 15, 2019

First Submission Date that Met QC Criteria

Mar 15, 2019

First Posted Date

Mar 18, 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

Jan 14, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

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

Virtual experiment : comparing the new method with conventional method of determining the depth of endotracheal intubation.

Detailed Description

Effective airway management is the primary concern of the anesthesiologist. The conventional method of determining the insertion length of the endotracheal tube, 21 cm for women and 23 cm for men, shows a high incidence of endobronchial intubations in the analyzed population.The aim of this study is form a new and safe practice habit by passing the endotracheal tube with the balloon just 2 cm below the vocal cords during intubation.

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

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the depth of primary insertion of tracheal tube		in a minute after intubation

Secondary Outcomes

Measure	Description	Time Frame
the distance from the corner of mouth to the carina		in a minute after intubation
the distance from the vocal cords to the carina		in a minute after intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

Patients with anatomical defects of the face, neck, or upper airway
Patients at risk for pulmonary aspiration of gastric content

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

adult patients who are scheduled for elective surgery under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital with Nanjing Medical University		Nanjing	Jiangsu	210029	China

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