NCT03392818

Brief Summary

To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 24, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

January 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 9, 2018

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

December 24, 2017

Last Update Submit

January 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The intubation time

    The intubation time defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until Uniblocker at the optimal position and this was done using a stopwatch.

    1 year

Study Arms (3)

formula

EXPERIMENTAL

Calculate the depth of intubation according to the formula of 0.1977\* patient's height - 4.2423

Other: formula

Fiberoptic bronchoscope

EXPERIMENTAL

intubation of Uniblocker under the Under the guidance of Fiberoptic bronchoscope

Device: Fiberoptic bronchoscope

The measured distance

EXPERIMENTAL

To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.

Other: The measured distance

Interventions

To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of Fiberoptic bronchoscope.

The measured distance
formulaOTHER

Calculate the depth of intubation according to the formula of 0.1977\* patient's height - 4.2423

formula

The intubation of Uniblocker under the guidance of Fiberoptic bronchoscope

Fiberoptic bronchoscope

Eligibility Criteria

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

You may qualify if:

  • Adult patients undergoing left side thoracic surgery
  • The thoracic surgery requiring a Uniblocker for one-lung ventilation

You may not qualify if:

  • Age\>70 or \<18 years
  • ASA classifications \>III
  • BMI \>35kg/m2
  • Modified Mallampati classification ≥III
  • Thoracic surgery within the last one month
  • Severe cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

RECRUITING

MeSH Terms

Interventions

Food, Formulated

Intervention Hierarchy (Ancestors)

Foods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ximing Qi

    The First Hospital of Qinhuangdao

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 24, 2017

First Posted

January 8, 2018

Study Start

January 7, 2018

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

January 9, 2018

Record last verified: 2017-12

Locations