Which is the Best Bedside Test to Detect Endobronchial Intubation?

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01232166
First received: October 29, 2010
Last updated: November 1, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Endobronchial Intubation
Other: Auscultation
Other: Observation of symmetric chest movements
Other: Tube depth
Other: All three

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Endotracheal Tube Insertion Depth Better Detects Endobronchial Intubation Than Bilateral Auscultation or Observation of Chest Movements - a Prospective Randomised Trial

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Sensitivity/Specificity to detect endobronchial intubation [ Time Frame: 1-5 minutes after intubation ] [ Designated as safety issue: Yes ]
    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


Enrollment: 160
Study Start Date: March 2004
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
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  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Univ. Prof. Chiari, Medical University; Department for Anesthesia and General Intensive Care
ClinicalTrials.gov Identifier: NCT01232166     History of Changes
Other Study ID Numbers: MUW464/2003
Study First Received: October 29, 2010
Last Updated: November 1, 2010
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

ClinicalTrials.gov processed this record on July 22, 2014