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

August 4, 2020 updated by: Sung Hye Byun, Daegu Catholic University Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daegu Catholic University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Institute of Medical Science, Daegu Catholic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-18-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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