Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656406
• Other study ID #: CR-18-111
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2020
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP) of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning.

Description:

It is essential to maintain proper cuff pressure in the endotracheal tube (ETT) when placing the ETT in the trachea in patients undergoing general anesthesia. Most of the literature recommend maintaining a pressure of 20-30 cmH2O to prevent cuff-related complications such as micro-aspiration or airway trauma. Proper pressure is also important for DLTs used in thoracic surgery. Furthermore, the cuff pressure of the ETT can change during the patient's positional changes. All things considered, we hypothesized that the change from supine to lateral decubitus position, which is essential for thoracic surgery would affect the BCP of the DLT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 or 2

2. Elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided DLT

Exclusion Criteria:

1. Patients requiring a right-sided DLT.

2. Patients with an intraluminal lesion in the left mainstem bronchus (LMB).

3. Patients with an anatomical problem in the tracheobronchial tree.

4. Patients with impaired lung such as chronic obstructive pulmonary disease.

5. Patients who refused to participate in this study.

Related Conditions & MeSH terms

• Lung Cancer
• Pneumothorax

Intervention

Behavioral:
• Lateral decubitus positioning
After the DLT intubation, the patient is placed in lateral decubitus position

Device:
• Cuff-manometer
The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning.

Locations

Country	Name	City	State
Korea, Republic of	Sung-Hye Byun	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center	Research Institute of Medical Science, Daegu Catholic University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Araki K, Nomura R, Urushibara R, Yoshikawa Y, Hatano Y. Bronchial cuff pressure change caused by left-sided double-lumen endobronchial tube displacement. Can J Anaesth. 2000 Aug;47(8):775-9. — View Citation

Athiraman U, Gupta R, Singh G. Endotracheal cuff pressure changes with change in position in neurosurgical patients. Int J Crit Illn Inj Sci. 2015 Oct-Dec;5(4):237-41. doi: 10.4103/2229-5151.170841. — View Citation

Wu CY, Yeh YC, Wang MC, Lai CH, Fan SZ. Changes in endotracheal tube cuff pressure during laparoscopic surgery in head-up or head-down position. BMC Anesthesiol. 2014 Aug 31;14:75. doi: 10.1186/1471-2253-14-75. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the maximum bronchial cuff pressure (BCP) which does not exceed 40 cmH2O with no air leak from supine to lateral decubitus position	A cuff-manometer will be connected to the valve of the pilot balloon of bronchial cuff via a three-way stopcock. And then, the BCP will be assessed, while inflating the cuff with air in 0.5 ml increments from 0 to 3.0 ml. If the BCP exceeds 40 cmH2O during expansion by increasing 0.5 ml from 0 to 3.0 ml, we will stop inflating the bronchial cuff with air and record the bronchial cuff volume (BCV) and BCP up to the last numerical value. During the pressure measurement, air leak or seal around the bronchial cuff will be assessed at each time point when inflating the cuff in 0.5 ml increments.	1. In supine position, 2 minutes after the completion of confirming the double-lumen endotracheal tube (DLT) position via fiberoptic bronchoscope (FOB) 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
Secondary	The incidence of the patients whose maximum BCP exceed 40 cmH2O after lateral positioning		1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
Secondary	The minimum BCV that is the smallest bronchial cuff volume without air leakage		1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB