NCT02943928

Brief Summary

laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

October 23, 2016

Last Update Submit

February 13, 2023

Conditions

Therapeutic Procedural Complication

Outcome Measures

Primary Outcomes (1)

  • Intubation Time

    Ten minutes

Study Arms (2)

laryngoscope and chest CT image

EXPERIMENTAL

First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis.

Device: laryngoscope and chest CT image

Traditional method by experience

EXPERIMENTAL

Operator inserted the double lumen tube by experience

Device: traditional method by experience

Interventions

laryngoscope and chest CT imageDEVICE

First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis

laryngoscope and chest CT image
traditional method by experienceDEVICE

Operator inserted the double lumen tube by experience

Traditional method by experience

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI less than 35 kg/m2
  • ASA classifications of I-III, modified Mallampati classification 1 or 2 general anesthesia were included-

You may not qualify if:

  • ASA class IV or V
  • Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

中国

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Interventions

Laryngoscopes

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Ximing Qi

    The First Hospital of Qinhuangdao

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2016

First Posted

October 25, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)