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

NCT03656406 | Completed

• 1 other identifier: CR-18-111
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Pneumothorax

Keywords

Double-lumen endotracheal tube; Cuff pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Interventions

Lateral decubitus positioning BEHAVIORAL

After the DLT intubation, the patient is placed in lateral decubitus position

Cuff-manometer DEVICE

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-70 years with an American Society of Anesthesiologists (ASA) physical status 1 or 2, who are scheduled to undergo elective lung surgery requiring lateral decubitus positioning and one-lung ventilation (OLV) using left-sided DLT

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1 or 2
• Elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided DLT

You may not qualify if:

• Patients requiring a right-sided DLT.
• Patients with an intraluminal lesion in the left mainstem bronchus (LMB).
• Patients with an anatomical problem in the tracheobronchial tree.
• Patients with impaired lung such as chronic obstructive pulmonary disease.
• Patients who refused to participate in this study.

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead
• Research Institute of Medical Science, Daegu Catholic University: collaborator

Study Sites (1)

Sung-Hye Byun

Daegu, 42472, South Korea

Location

Related Publications (4)

• 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.

  PMID: 25210501 BACKGROUND

• 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.

  PMID: 26807392 BACKGROUND

• 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. doi: 10.1007/BF03019480.

  PMID: 10958094 BACKGROUND

• Kim E, Kim IY, Byun SH. Effect of lateral positioning on the bronchial cuff pressure of a left-sided double-lumen endotracheal tube during thoracic surgery: study protocol for a prospective observational study. BMJ Open. 2019 Mar 30;9(3):e026606. doi: 10.1136/bmjopen-2018-026606.

  PMID: 30928955 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pneumothorax

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 4, 2018
• Study Start: September 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)