Insertion Depth of Left-sided Double-lumen Tube: a New Predictive Formula

NCT04329416 | Completed DMC

• 1 other identifier: E-18-3064
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The authors developed a formula for predicting the accurate depth of DLT insertion into the appropriate bronchus based on height as follows \[The predicted insertion depth of left DLT (cm) equals 0.249 × (BH)0.916\] \[R\]. That pilot study showed comparable correlations between five formulae \[Brodsky et al, Bahk and Oh R, Takita et al, Chow et al, Lin\]. However, that formula developed has not been validated yet. We hypothesized that previously published formula would predict the accurate depth of left-sided DLT insertion. We aimed to investigate the efficacy of this formula to estimate the optimum insertion depth of the DLT using a flexible bronchoscope and decrease the incidence of DLT displacement into the appropriate bronchus, the need for bronchoscopic adjustment, and complications including soreness of throat and mucosal injury.

Conditions

Thoracic Surgery; One Lung Ventilation; Left-sided Double Lumen Tube

Outcome Measures

Primary Outcomes (1)

• The rate of optimum position of the double-lumen tube

  The rate of optimum position of a left-sided DLT without further adjustments, defined as the inflated endobronchial cuff is placed in the left main bronchus just below the carina without herniation

  for 15 minutes after double-lumen tube insertion

Secondary Outcomes (12)

• The calculated predicted depth of insertion

  immediately before induction of general anesthesia

• The initial depth of insertion

  for 15 minutes after double-lumen tube insertion

• Position of the double-lumen tube with the flexible bronchoscope

  for 15 minutes after double-lumen tube insertion

• The need for bronchoscopic adjustments

  for 15 minutes after double-lumen tube insertion

• The final correct depth of insertion

  for 15 minutes after double-lumen tube insertion

Study Arms (1)

Predicted depth of insertion

OTHER

The predicted insertion depth of the DLT was calculated using the formula \[0.249 x (BH) 0.916\] before induction of anesthesia using an application on the smartphone

Other: Predicted depth of insertion; Other: Optimized depth of insertion; Other: Adjustment of depth of insertion

Interventions

Predicted depth of insertion OTHER

A left-sided double-lumen tube was introduced beyond the vocal cords when the train-of-four stimulation of the ulnar nerve revealed 1 or 2 twitches, the stylet was removed, the double-lumen tube was rotated 90° counterclockwise and then advanced blindly to the predicted depth of insertion.

Predicted depth of insertion

Optimized depth of insertion OTHER

The optimal position of the double-lumen tube, defined as the inflated endobronchial cuff is placed in the left main bronchus just below the carina without herniation, which was confirmed using a flexible bronchoscope in both supine and lateral decubitus positions.

Predicted depth of insertion

Adjustment of depth of insertion OTHER

If the endobronchial cuff was placed too deeply or too proximal, subsequently, the double-lumen tube was withdrawn or advanced, respectively, using the flexible bronchoscope until the optimum position of the double-lumen tube was achieved.

Predicted depth of insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent thoracic surgery
• Using a left-sided double-lumen tube for one-lung ventilation

You may not qualify if:

• Anticipated or known difficult airway
• Refuse to sign the consent
• Withdraw the consent

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead
• King Saud University: collaborator

Study Sites (1)

King Saud University

Riyadh, 11472, Saudi Arabia

Location

Study Officials

• Abdelazeem A Eldawlatly, MD

  Professor of Anesthesia, College of Medicine, King Saud University

  STUDY CHAIR

• Mohamed R El Tahan, MD

  Associate Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care, Imam Abdulrahman Bin Faisal University (formerly, University of Dammam), Dammam, Saudi Arabia,

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective observational single-center open-label study

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 1, 2020
• Study Start: May 7, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 15, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Unlimited time starting after publishing the paper

Locations

SA (1)