Which is the Best Bedside Test to Detect Endobronchial Intubation?

November 1, 2010 updated by: Medical University of Vienna

Endotracheal Tube Insertion Depth Better Detects Endobronchial Intubation Than Bilateral Auscultation or Observation of Chest Movements - a Prospective Randomised Trial

Background: Endotracheal intubation has become a well established standard in protecting the airway during surgical procedures, and in emergency situations. Serious complications can occur from the incorrect placement of an endotracheal tube in a mainstem bronchus. If unrecognized it can lead to hypoxemia secondary to atelectasis of the unventilated lung and hyperinflation of the intubated lung, which can result in barotrauma. As bedside method the golden standard to verify the correct endotracheal tube placement is bilateral ausculation of the chest. However this is not always satisfactory, as breath sounds can be transmitted to the opposite side of the chest in spite of endobronchial intubation. Therefore other clinical tests to verify the correct endotracheal tube placement have become part of daily clinical practice, like observation of symmetric chest movements, and use of the cm markings printed on the endotracheal tube. However so far no study investigated which of these bedside clinical methods works best in detecting an inadvertently placed endobronchial tube in adults. We therefore designed a study to compare three different bedside methods to verify endotracheal or endobronchial tube placement.

Objective: To determine which of four commonly used bedside methods of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity.

Design: Prospective randomized, blinded study. Setting: Tertiary, academic hospital, department of anaesthesia. Participants: 160 consecutive ASA I or II patients, aged 19-75 years, scheduled for elective gynaecological or urological surgery.

Interventions: Patients were randomly assigned to eight study groups. In four groups, an endotracheal tube (ETT) was fiberoptically positioned 2.5-4.0 cm above the carina, whereas in the other four groups the tube was positioned in the right mainstem bronchus. The four groups differed in the bedside test used to verify the position of the endotracheal tube. First-year residents and experienced anaesthesiologists independently performed one of the following randomly assigned bedside tests in each patient in an effort to determine whether the tube was properly positioned in the trachea: 1) bilateral auscultation of the chest (Auscultation); 2) observation and palpation of symmetric chest movements (Observation); 3) estimating the position of the ETT by the insertion depth (Tube Depth); and, 4) a combination of all three mentioned tests (All Three).

Main outcome measures: Correct and incorrect judgements of endotracheal tube (ETT) position as independently assessed by first-year anaesthesia residents and experienced anaesthesiologists with each of the four bedside tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

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

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ASA I or II patients, aged 19-75 years, scheduled for elective gynaecological or urological surgery that needs endotracheal intubation.

Exclusion Criteria:

  • Pre-existing lung disease, pleural effusion, anticipated difficult airway, known endobronchial or tracheal lesions, or patients at risk for aspiration of gastric contents.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endobronchial Intubation, Auscultation
In this arm, the endotracheal tube will be positioned in the right main stem bronchus under direct visualization through a fiberoptic bronchoscope. The study anesthesiologists will then perform bilateral auscultation of the lungs only, with the patient's thorax and head covered with blankets to blind participants to thorax movements and ETT insertion depth (Group Auscultation, n=20)
Other: Auscultation
Active Comparator: Endobronchial Intubation, Observation
In this arm, the endotracheal tube (ETT) will be positioned in the right main stem bronchus under direct visualization through a fiberoptic bronchoscope. To determine the position of the ETT the study anesthesiologists will then perform observation and palpation of symmetric chest movements without auscultation of the lungs, with the patient's head covered with blankets to blind participants to ETT insertion depth (Group Observation, n=20);
Other: Observation of symmetric chest movements
Active Comparator: Endobronchial intubation, tube depth
In this arm, the endotracheal tube (ETT) will be positioned in the right main stem bronchus under direct visualization through a fiberoptic bronchoscope. To determine the position of the ETT the study anesthesiologists will then estimate ETT position by observing the ETT cm scale without lung auscultation, with the patient's thorax covered by blankets to blind participants to thorax movements (Group Tube Depth, n=20)
Other: Tube depth
Active Comparator: Endobronchial intubation, all three
In this arm, the endotracheal tube (ETT) will be positioned in the right main stem bronchus under direct visualization through a fiberoptic bronchoscope. To determine the position of the ETT the study anesthesiologists will then perform a combination of auscultation, observation and tube depth
Other: All three
Experimental: Endotracheal Intubation, Auscultation
In this arm, the endotracheal tube will be positioned in the trachea, 2,5-4cm above the carina under direct visualization through a fiberoptic bronchoscope. The study anesthesiologists will then perform bilateral auscultation of the lungs only, with the patient's thorax and head covered with blankets to blind participants to thorax movements and ETT insertion depth (Group Auscultation, n=20)
Other: Auscultation
Active Comparator: Endotracheal Intubation, observation
In this arm, the endotracheal tube (ETT) will be positioned in the trachea, 2,5-3cm above the carina under direct visualization through a fiberoptic bronchoscope. To determine the position of the ETT the study anesthesiologists will then perform observation and palpation of symmetric chest movements without auscultation of the lungs, with the patient's head covered with blankets to blind participants to ETT insertion depth (Group Observation, n=20);
Other: Observation of symmetric chest movements
Active Comparator: Endotracheal intubation, tube depth
In this arm, the endotracheal tube (ETT) will be positioned in the trachea, 2,5 - 4 cm above the carina under direct visualization through a fiberoptic bronchoscope. To determine the position of the ETT the study anesthesiologists will then estimate ETT position by observing the ETT cm scale without lung auscultation, with the patient's thorax covered by blankets to blind participants to thorax movements (Group Tube Depth, n=20)
Other: Tube depth
Active Comparator: Endotracheal intubation, all three
In this arm, the endotracheal tube (ETT) will be positioned 2,5-4cm above the carina under direct visualization through a fiberoptic bronchoscope. To determine the position of the ETT the study anesthesiologists will then perform a combination of auscultation, observation and tube depth
Other: All three

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity/Specificity to detect endobronchial intubation
Time Frame: 1-5 minutes after intubation
First-year residents and experienced anaesthesiologists independently performe one of four randomly assigned bedside tests in each patient to determine whether the tube was positioned in the trachea or endobronchially
1-5 minutes after intubation

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Publications and helpful links

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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

March 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • MUW464/2003

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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