Chest CT for the Placement of the Uniblocker

NCT03008473 | Completed DMC

• 1 other identifier: 20161229
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Video laryngoscope and chest CT iminge for the placement of the Uniblocker

Conditions

Therapeutic Procedural Complication

Outcome Measures

Primary Outcomes (1)

• Intubation Time

  5min

Study Arms (2)

video laryngoscope and chest CT iminge

EXPERIMENTAL

First,the operator calculate the distance between the carina and the glottis by CT image and make a marker on the Uniblocker. Then the operator inserted the Uniblocker into the trachea and advanced toward the left main-stem bronchus via the video laryngoscope untill see marker just at the glottis then stopped the insertion .Second, a single lumen tube with appropriate size was intubated via video laryngoscope into the appropriate depth.Third,the Fiberoptic bronchoscopy(FOB) was inserted into single lumen tube to assess the position of the Uniblocker and the injuries of bronchi and carina

Device: video laryngoscope and chest CT iminge

Conventional intubation of Uniblocker

EXPERIMENTAL

First, a conventional single lumen tube (SLT) was inserted into trachea at optimal depth via video laryngoscope. Second, a Uniblocker was inserted through SLT and directed to the left main-stem bronchus. Third, an FOB was inserted into the SLT to adjust the Uniblocker to optimal position and assessed the injuries of bronchi and carina.

Device: Conventional intubation of uniblocker

Interventions

video laryngoscope and chest CT iminge DEVICE

video laryngoscope and chest CT iminge

Conventional intubation of uniblocker DEVICE

Conventional intubation of Uniblocker

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 Under general anesthesia

You may not qualify if:

• Age younger than 18 yr or older than 65 yr
• ASA class IV or V
• Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

The first hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

Study Officials

• Ximing Qi, PHD

  The First Hospital of Qinhuangdao

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: January 1, 2017
• Primary Completion: September 24, 2017
• Study Completion: September 24, 2017
• Last Updated: February 23, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)