Clinical trial NCT04329416: Insertion Depth of Left-sided Double-lumen Tube: a New Predictive Formula
Official title: Efficacy of Height-Based Formula to Predict Insertion Depth of Left-Sided Double Lumen Tube. A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
One Lung Ventilation
Left-sided Double Lumen Tube
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
Collaborators: name: King Saud University
First posted: 2020-04-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective observational single-center open-label study
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of optimum position of the double-lumen tube
timeFrame: for 15 minutes after double-lumen tube insertion
Secondary outcomes:
measure: The calculated predicted depth of insertion
timeFrame: immediately before induction of general anesthesia
measure: The initial depth of insertion
timeFrame: for 15 minutes after double-lumen tube insertion
measure: Position of the double-lumen tube with the flexible bronchoscope
timeFrame: for 15 minutes after double-lumen tube insertion
measure: The need for bronchoscopic adjustments
timeFrame: for 15 minutes after double-lumen tube insertion
measure: The final correct depth of insertion
timeFrame: for 15 minutes after double-lumen tube insertion
measure: Time to final correct double-lumen tube positioning
timeFrame: for 25 minutes after double-lumen tube insertion
measure: Changes in heart rate
timeFrame: for 25 minutes after double-lumen tube insertion
measure: Changes in mean arterial blood pressure
timeFrame: for 25 minutes after double-lumen tube insertion
measure: Changes in peripheral oxygen saturation
timeFrame: for 25 minutes after double-lumen tube insertion
measure: Degree of lung collapse
timeFrame: for 30 minutes after start of surgery
measure: The incidence of soreness of throat
timeFrame: for 24 hours after start of surgery
measure: The incidence of mucosal injury
timeFrame: for 40 minutes after double-lumen tube insertion
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: Professor of Anesthesia, College of Medicine, King Saud University
name: Abdelazeem A Eldawlatly, MD
role: STUDY_CHAIR
affiliation: Associate Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care, Imam Abdulrahman Bin Faisal University (formerly, University of Dammam), Dammam, Saudi Arabia,
name: Mohamed R El Tahan, MD
role: STUDY_DIRECTOR
References: