Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube

• Sponsor: Ajou University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03173443
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 31.1

Study Details

Study Description

Brief Summary

One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT.

The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult	Device: single lumen tube and bronchial blocker; Device: double lumen tube	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Device Feasibility
• Official Title: Comparison of Insertion Time Over Fiberoptic Bronchoscope Between Double Lumen Tube and Single Lumen Tube
• Actual Study Start Date: May 31, 2017
• Actual Primary Completion Date: Aug 26, 2017
• Actual Study Completion Date: Aug 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single lumen tube fiberoptic intubation with single lumen tube with bronchial blocker.	Device: single lumen tube and bronchial blocker; fiberoptic intubation with single lumen tube and bronchial blocker
Experimental: double lumen tube fiberoptic intubation with double lumen tube.	Device: double lumen tube; fiberoptic intubation with double umen tube

Outcome Measures

Primary Outcome Measures

1. insertion time [at anesthesia induction]

   time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2

Exclusion Criteria:

• abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI > 35

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou universiry hospital	Suwon	Gyeonggi-do	Korea, Republic of	16499

Sponsors and Collaborators

• Ajou University School of Medicine

Investigators

• Principal Investigator: Dae Hee Kim, M.D., Ajou unversity hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DAE HEE KIM, Assistant Professor, Ajou University School of Medicine
• ClinicalTrials.gov Identifier: NCT03173443
• Other Study ID Numbers: AJIRB-DEV-OBS-17-70
• First Posted: Jun 1, 2017
• Last Update Posted: Jan 9, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by DAE HEE KIM, Assistant Professor, Ajou University School of Medicine: Fiberoptic intubation; double lumen tube

Study Results

No Results Posted as of Jan 9, 2018