An Innovative Approach for Uniblocker Intubation

An Innovative Approach for Accurately Predicting the Optimal Insertion Depth of Uniblocker Without Fiberoptic Bronchoscope Assistance

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.

Study Overview

• Status: Unknown
• Conditions: Therapeutic Procedural Complication
• Intervention / Treatment: Other: formula; Device: Fiberoptic bronchoscope; Other: The measured distance

Detailed Description

In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • Recruiting
      • The First Hospital of Qinhuangdao
      • Contact: Zhuo Liu; Phone Number: +86-03355908581; Email: liuzhuo2011@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Age>70 or <18 years
2. ASA classifications >III
3. BMI >35kg/m2
4. Modified Mallampati classification ≥III
5. Thoracic surgery within the last one month
6. Severe cardiopulmonary disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: formula; Calculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423	Other: formula; Calculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423
Experimental: Fiberoptic bronchoscope; intubation of Uniblocker under the Under the guidance of Fiberoptic bronchoscope	Device: Fiberoptic bronchoscope; The intubation of Uniblocker under the guidance of Fiberoptic bronchoscope
Experimental: The measured distance; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2018
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: December 24, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 6, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 966169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No