Displacement Between PVC and Silicon DLT

NCT02691468 | Completed Results DMC

• 1 other identifier: YeungnamUDLT
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare difference of displacement between Polyvinyl Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position from supine to lateral in thoracic surgery.

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure; Surgical Procedure, Unspecified

Keywords

one lung ventilation; double lumen endobronchial tube; displacement; Fiberoptic bronchoscope

Outcome Measures

Primary Outcomes (1)

• the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position

  The tracheal distance was defined as the distance between the distal tip of the tracheal lumen and tracheal carina whereas the bronchial distance was defined as that between the bronchial carina and distal tip of endobronchial lumen. The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively. Clinically significant displacement was defined when the DLT was deviated by more than 10 mm from the initial correct position, regardless of the direction of displacement.

  from supine to lateral decubitus position during surgery

Secondary Outcomes (1)

• the Incidence of Critical Malposition of DLTs

  from supine to lateral decubitus position

Study Arms (2)

PVC DLT

ACTIVE COMPARATOR

After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope. The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position . The second set of measurements is taken in lateral position after position change. The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.

Device: PVC DLT

silicon DLT

ACTIVE COMPARATOR

After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope. The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position . The second set of measurements is taken in lateral position after position change. The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.

Device: silicon DLT

Interventions

PVC DLT DEVICE

PVC DLT is type of double lumen tube that is composed of PVC

Also known as: PVC double-lumen tube

PVC DLT

silicon DLT DEVICE

silicon DLT is type of double lumen tube that is composed of silicon

Also known as: silicon double-lumen tube

silicon DLT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient required differential lung ventilation in elective thoracic surgery American society of Anesthesiologist physical status(ASA PS) 1\~3

You may not qualify if:

• emergency surgery, difficult intubation, poor lung function to accomplish OLV during surgery

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Related Publications (3)

• Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.

  PMID: 3674473 BACKGROUND

• Desiderio DP, Burt M, Kolker AC, Fischer ME, Reinsel R, Wilson RS. The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):595-8. doi: 10.1016/s1053-0770(97)90011-2.

  PMID: 9263092 BACKGROUND

• Yoon TG, Chang HW, Ryu HG, Kwon TD, Bahk JH. Use of a neck brace minimizes double-lumen tube displacement during patient positioning. Can J Anaesth. 2005 Apr;52(4):413-7. doi: 10.1007/BF03016286.

  PMID: 15814758 BACKGROUND

Related Links

• Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology.
• The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning.
• Use of a neck brace minimizes double-lumen tube displacement during patient positioning.

Limitations and Caveats

First, the position change and surgical manipulation may have a combined. Second, we did not monitor the pressure and volume of air injected into the bronchial cuff. Third, we did not investigate ideal position of DLT.

Results Point of Contact

• Title: Sung Mee Jung, M.D
• Organization: Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea

applejsm@gmail.com

+82-53-620-3368

Study Officials

• Sung Mee applejsm@gmail.com, MD

  Yeungnam University College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 10, 2021
• Results First Posted: December 23, 2019

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)