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NCT Number: NCT04329416

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

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.

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Key information

Conditions

Thoracic Surgery Left-sided Double Lumen Tube One Lung Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University

Riyadh, 11472, Saudi Arabia

About this study

Accurate placement of the double-lumen tube [DLT], the commonly used tool to provide one-lung ventilation during thoracic surgery, is a real challenge for the thoracic anesthesiologists. Optimal DLT depth, defined as the blue endobronchial cuff below the carina, would decrease the incidence of obstructing the trachea and the contralateral bronchus (Brodsky). Additionally, deep insertion of the bronchial cuff of the DLT would obstruct the upper lobe bronchus (Brodsky). The careful adjustment of the depth and optimal positioning of the DLT using a flexible fiberoptic bronchoscope need a skilled anesthesiologist to reduce the time to DLT intubation. (Charles D. Boucek et al)

There are several methods have been described to predict the proper depth of DLT insertion. Chow et al. documented the validity of the developed formula based on the clavicular-to-carinal distance of trachea and height in 78% of patients studied. Brodsky et al. demonstrated that a height-and-gender-based formula could predict the depth of DLT insertion. Liu et al. reported an accurate depth of DLT insertion in 90% of patients studied measuring the distance between the vocal cord and carina according to the chest CT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. The rate of optimum position of the double-lumen tube

    Time frame: for 15 minutes after double-lumen tube insertion

    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

Secondary outcomes

  1. The calculated predicted depth of insertion

    Time frame: immediately before induction of general anesthesia

    The predicted insertion depth of the DLT was calculated using the formula [0.249 x (BH) 0.916] using an application an application on the smart phone

  2. The initial depth of insertion

    Time frame: for 15 minutes after double-lumen tube insertion

    The "initial depth of insertion," was measured using the external centimeter markings on the DLT's lumen at the level of incisors

  3. Position of the double-lumen tube with the flexible bronchoscope

    Time frame: for 15 minutes after double-lumen tube insertion

    The position of the DLT with the flexible bronchoscope would be rated either (1) optimally placed, (2) too far out, or (3) too far in

  4. The need for bronchoscopic adjustments

    Time frame: for 15 minutes after double-lumen tube insertion

    If the endobronchial cuff was placed too deeply or too proximal, subsequently, the DLT was withdrawn or advanced, respectively, using the flexible bronchoscope until the optimum position of the DLT was achieved. The optimizing maneuvers were recorded

  5. The final correct depth of insertion

    Time frame: for 15 minutes after double-lumen tube insertion

    the "final correct depth of insertion", defined as the distance from the distal opening of the bronchial lumen to the corner of the mouth, was measured with a flexible bronchoscope passing through the bronchial lume

  6. Time to final correct double-lumen tube positioning

    Time frame: for 25 minutes after double-lumen tube insertion

    Time to final correct DLT positioning from time of laryngoscopy was recorded

  7. Changes in heart rate

    Time frame: for 25 minutes after double-lumen tube insertion

    Postintubation changes in heart rate was recorded

  8. Changes in mean arterial blood pressure

    Time frame: for 25 minutes after double-lumen tube insertion

    Postintubation changes in mean arterial blood pressure was recorded

  9. Changes in peripheral oxygen saturation

    Time frame: for 25 minutes after double-lumen tube insertion

    Postintubation changes in peripheral oxygen saturation was recorded

  10. Degree of lung collapse

    Time frame: for 30 minutes after start of surgery

    degree of lung collapse was rated as excellent, good, poor, or very poor

  11. The incidence of soreness of throat

    Time frame: for 24 hours after start of surgery

    Patients were asked about the occurrence and severity of postoperative sore throat

  12. The incidence of mucosal injury

    Time frame: for 40 minutes after double-lumen tube insertion

    The incidence of mucosal injury using the flexible bronchoscope was reported after intubation using the double-lumen tube

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Collaborators

  • King Saud University

Registry information

Official study title

Efficacy of Height-Based Formula to Predict Insertion Depth of Left-Sided Double Lumen Tube. A Prospective Observational Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2020
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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