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NCT Number: NCT03656406

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pleural Diseases Pneumothorax Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sung-Hye Byun

Daegu, 42472, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

    Time frame: 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

    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.

Secondary outcomes

  1. The incidence of the patients whose maximum BCP exceed 40 cmH2O after lateral positioning

    Time frame: 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

  2. The minimum BCV that is the smallest bronchial cuff volume without air leakage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Collaborators

  • Research Institute of Medical Science, Daegu Catholic University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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