Which is the Best Bedside Test to Detect Endobronchial Intubation?

Endobronchial Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232166
• Other study ID #: MUW464/2003
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: November 1, 2010
• Start date: March 2004
• Est. completion date: June 2009

Study information

• Verified date: October 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endobronchial Intubation

Intervention

Other:
• Auscultation

• Observation of symmetric chest movements

• Tube depth

• All three

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity/Specificity to detect endobronchial 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	Yes