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Which is the Best Bedside Test to Detect Endobronchial Intubation?

NCT ID: NCT01232166

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endobronchial Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Auscultation

Intervention Type OTHER

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);

Group Type ACTIVE_COMPARATOR

Observation of symmetric chest movements

Intervention Type OTHER

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)

Group Type ACTIVE_COMPARATOR

Tube depth

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

All three

Intervention Type OTHER

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)

Group Type EXPERIMENTAL

Auscultation

Intervention Type OTHER

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);

Group Type ACTIVE_COMPARATOR

Observation of symmetric chest movements

Intervention Type OTHER

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)

Group Type ACTIVE_COMPARATOR

Tube depth

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

All three

Intervention Type OTHER

Interventions

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Auscultation

Intervention Type OTHER

Observation of symmetric chest movements

Intervention Type OTHER

Tube depth

Intervention Type OTHER

All three

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University; Department for Anesthesia and General Intensive Care

References

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Sitzwohl C, Langheinrich A, Schober A, Krafft P, Sessler DI, Herkner H, Gonano C, Weinstabl C, Kettner SC. Endobronchial intubation detected by insertion depth of endotracheal tube, bilateral auscultation, or observation of chest movements: randomised trial. BMJ. 2010 Nov 9;341:c5943. doi: 10.1136/bmj.c5943.

Reference Type DERIVED
PMID: 21062875 (View on PubMed)

Other Identifiers

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MUW464/2003

Identifier Type: -

Identifier Source: org_study_id