Displacement Between PVC and Silicon DLT

• Sponsor: Yeungnam University College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02691468
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endotracheal Tube Wrongly Placed During Anesthetic Procedure; Surgical Procedure, Unspecified	Device: PVC DLT; Device: silicon DLT	N/A

Detailed Description

Lung isolation and differential lung ventilation, resulting in collapse of operative lung and ventilation of non-operating lung (one lung ventilation; OLV) are essential for thoracic surgery in lung, esophagus and thoracic aorta.

DLT, consisted of tracheal and bronchial lumens, is commonly used to perform differential lung ventilation. The correct position of each lumen in trachea and main bronchus is essential for successful OLV. However, DLT displacement occurs commonly while patients are changed position from the supine to the lateral. The deleterious consequences of a malpositioned DLT can be substantial, even life-threatening including severe hypoxemia.

Considering displacement of DLT during position change and surgical traction, previous studies recommended endobronchial cuff of DLT should be positioned at 0.5cm below the tracheal carina when using left-sided DLT. However, it is based on the data from several research conducted by PVC DLT.

These days, Silicon DLT, different in material from PVC DLT, is also widely used in clinical practice. Silicon DLT is different in not only position of ballon but also distance of each lumen. Furthermore,there are no identified studies about the displacement of silicon DLT during patient position change in thoracic surgery.

Therefore, it is necessary to measure the movement of silicon DLT during positional change from supine to lateral for finding the proper positioning of DLT.

The investigators compare the difference of displacement between PVC DLT and silicon DLT distance during positional change from supine to lateral by fiberotic bronchoscope. And the investigators try to find proper position of PVC and silicon DLT, respectively, to perform safe and successful OLV during thoracic surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Comparison of Displacement Between Polyvinyl Chloride(PVC) and Silicon Double-Lumen Endobronchial Tubes(DLT) During Change of Position
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PVC DLT 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; PVC DLT is type of double lumen tube that is composed of PVC; Other Names: PVC double-lumen tube
Active Comparator: silicon DLT 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; silicon DLT is type of double lumen tube that is composed of silicon; Other Names: silicon double-lumen tube

Outcome Measures

Primary Outcome Measures

1. the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position [from supine to lateral decubitus position during surgery]

   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.

Secondary Outcome Measures

1. the Incidence of Critical Malposition of DLTs [from supine to lateral decubitus position]

   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. The critical malposition was defined when the DLT was required repostion for successful OLV during position change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yeungnam University Hospital	Daegu		Korea, Republic of	42415

Sponsors and Collaborators

• Yeungnam University College of Medicine

Investigators

• Principal Investigator: Sung Mee [e-mail], MD, Yeungnam University College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 1, 2017

More Information

Additional Information:

• 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.

Publications

• 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.
• 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.
• 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.

• Responsible Party: Sung Mee Jung, Associate Professor, Yeungnam University College of Medicine
• ClinicalTrials.gov Identifier: NCT02691468
• Other Study ID Numbers: YeungnamUDLT
• First Posted: Feb 25, 2016
• Last Update Posted: Aug 10, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sung Mee Jung, Associate Professor, Yeungnam University College of Medicine: one lung ventilation; double lumen endobronchial tube; displacement; Fiberoptic bronchoscope
• Additional relevant MeSH terms: Silicon

Study Results

Participant Flow

Recruitment Details	One hundred and eight adult patients, aged between 18 and 75 years, American Society of Anesthesiologists (ASA) physical status 1 ~ 3 scheduled for elective thoracic surgery were enrolled.
Pre-assignment Detail	Patients with emergency surgery, difficult intubation, poor lung function to accomplish one-lung ventilation (OLV) during surgery were excluded.

Arm/Group Title	Polyvinyl Chloride (PVC) Double Lumen Tube (DLT)	Silicon Double Lumen Tube (DLT)
Arm/Group Description	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. PVC DLT: PVC DLT is type of double lumen tube that is composed of polyvinlyl chloride.	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. silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
Period Title: Overall Study
STARTED	54	54
COMPLETED	48	52
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	PVC DLT	Silicon DLT	Total
Arm/Group Description	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. PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC	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. silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon	Total of all reporting groups
Overall Participants	54	54	108
Age (Count of Participants)
<=18 years	1 1.9%	0 0%	1 0.9%
Between 18 and 65 years	20 37%	47 87%	67 62%
>=65 years	33 61.1%	7 13%	40 37%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.7 (16.1)	57.8 (14.9)	57.3 (15.5)
Sex: Female, Male (Count of Participants)
Female	18 33.3%	18 33.3%	36 33.3%
Male	36 66.7%	36 66.7%	72 66.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position
Description	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.
Time Frame	from supine to lateral decubitus position during surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PVC DLT	Silicon DLT
Arm/Group Description	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. PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC	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. silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
Measure Participants	48	52
Count of Participants [Participants]	17 31.5%	18 33.3%

2. Secondary Outcome

Title	the Incidence of Critical Malposition of DLTs
Description	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. The critical malposition was defined when the DLT was required repostion for successful OLV during position change
Time Frame	from supine to lateral decubitus position

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PVC DLT	Silicon DLT
Arm/Group Description	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. PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC	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. silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
Measure Participants	48	52
Number [participants]	4 7.4%	4 7.4%

Adverse Events

Time Frame	from induction of anesthesia through study completion, an average of 5 hours
Adverse Event Reporting Description	Hypoxemia : oxygen saturation less than 93%
Arm/Group Title	PVC DLT		Silicon DLT
Arm/Group Description	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. PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC		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. silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
All Cause Mortality
	PVC DLT		Silicon DLT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)
Serious Adverse Events
	PVC DLT		Silicon DLT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	PVC DLT		Silicon DLT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.