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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03656406
Other study ID # CR-18-111
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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