Thoracic SurgeryNCT04329416
Insertion Depth of Left-sided Double-lumen Tube: a New Predictive Formula
A study testing Predicted depth of insertion, Optimized depth of insertion and Adjustment of depth of insertion in people with Thoracic Surgery and One Lung Ventilation, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, One Lung Ventilation, Left-sided Double Lumen Tube
- What is being tested?
- Predicted depth of insertion, Optimized depth of insertion and Adjustment of depth of insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 May 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent thoracic surgery
- Using a left-sided double-lumen tube for one-lung ventilation
Who cannot join
- Anticipated or known difficult airway
- Refuse to sign the consent
- Withdraw the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Height-Based Formula to Predict Insertion Depth of Left-Sided Double Lumen Tube. A Prospective Observational Study
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.
Read the 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.
- Being tested
- Predicted depth of insertion, Optimized depth of insertion, Adjustment of depth of insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predicted depth of insertionOther
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 insertionOther
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 insertionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Predicted depth of insertion; Other: Optimized depth of insertion; Other: Adjustment of depth of insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: for 15 minutes after double-lumen tube insertion
Secondary outcomes (12)
The calculated predicted depth of insertion
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
Measured: immediately before induction of general anesthesia
The initial depth of insertion
The "initial depth of insertion," was measured using the external centimeter markings on the DLT's lumen at the level of incisors
Measured: for 15 minutes after double-lumen tube insertion
Position of the double-lumen tube with the flexible bronchoscope
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
Measured: for 15 minutes after double-lumen tube insertion
The need for bronchoscopic adjustments
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
Measured: for 15 minutes after double-lumen tube insertion
The final correct depth of 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
Measured: for 15 minutes after double-lumen tube insertion
Time to final correct double-lumen tube positioning
Time to final correct DLT positioning from time of laryngoscopy was recorded
Measured: for 25 minutes after double-lumen tube insertion
Changes in heart rate
Postintubation changes in heart rate was recorded
Measured: for 25 minutes after double-lumen tube insertion
Changes in mean arterial blood pressure
Postintubation changes in mean arterial blood pressure was recorded
Measured: for 25 minutes after double-lumen tube insertion
Changes in peripheral oxygen saturation
Postintubation changes in peripheral oxygen saturation was recorded
Measured: for 25 minutes after double-lumen tube insertion
Degree of lung collapse
degree of lung collapse was rated as excellent, good, poor, or very poor
Measured: for 30 minutes after start of surgery
The incidence of soreness of throat
Patients were asked about the occurrence and severity of postoperative sore throat
Measured: for 24 hours after start of surgery
The incidence of mucosal injury
The incidence of mucosal injury using the flexible bronchoscope was reported after intubation using the double-lumen tube
Measured: for 40 minutes after double-lumen tube insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start7 May 2019
- Primary completion1 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective observational single-center open-label study
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Sponsor
- Investigators
- Abdelazeem A Eldawlatly, MD, Study chair, Professor of Anesthesia, College of Medicine, King Saud UniversityMohamed R El Tahan, MD, Study director, Associate Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care, Imam Abdulrahman Bin Faisal University (formerly, University of Dammam), Dammam, Saudi Arabia,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329416
- Sponsor's protocol ID
- E-18-3064
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, the anonymized database would be shared after publishing the paper
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Height-Based Formula to Predict Insertion Depth of Left-Sided Double Lumen Tube. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04329416
- Acronym / sponsor ID
- E-18-3064
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective observational single-center open-label study
| Arm | Type | Receives |
|---|---|---|
| Predicted depth of insertion | Other | Other: Predicted depth of insertion, Other: Optimized depth of insertion, Other: Adjustment of depth of insertionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Underwent thoracic surgery
- Using a left-sided double-lumen tube for one-lung ventilation
Key exclusion criteria (3 listed)
- Anticipated or known difficult airway
- Refuse to sign the consent
- Withdraw the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predicted depth of insertionA 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. | Other | Predicted depth of insertion |
| Optimized depth of insertionThe 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. | Other | Predicted depth of insertion |
| Adjustment of depth of insertionIf 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. | Other | Predicted depth of insertion |
Primary outcome
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
12 secondary outcomes
The calculated predicted depth of insertion
Time frame: immediately before induction of general anesthesia
The initial depth of insertion
Time frame: for 15 minutes after double-lumen tube insertion
Position of the double-lumen tube with the flexible bronchoscope
Time frame: for 15 minutes after double-lumen tube insertion
The need for bronchoscopic adjustments
Time frame: for 15 minutes after double-lumen tube insertion
The final correct depth of insertion
Time frame: for 15 minutes after double-lumen tube insertion
Time to final correct double-lumen tube positioning
Time frame: for 25 minutes after double-lumen tube insertion
Changes in heart rate
Time frame: for 25 minutes after double-lumen tube insertion
Changes in mean arterial blood pressure
Time frame: for 25 minutes after double-lumen tube insertion
Changes in peripheral oxygen saturation
Time frame: for 25 minutes after double-lumen tube insertion
Degree of lung collapse
Time frame: for 30 minutes after start of surgery
The incidence of soreness of throat
Time frame: for 24 hours after start of surgery
The incidence of mucosal injury
Time frame: for 40 minutes after double-lumen tube insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, the anonymized database would be shared after publishing the paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelazeem A Eldawlatly, MD study chair
Professor of Anesthesia, College of Medicine, King Saud University
Mohamed R El Tahan, MD study director
Associate Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care, Imam Abdulrahman Bin Faisal University (formerly, University of Dammam), Dammam, Saudi Arabia,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predicted depth of insertion, Optimized depth of insertion and Adjustment of depth of insertion in people with Thoracic Surgery and One Lung Ventilation, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of optimum position of the double-lumen tube (time frame: for 15 minutes after double-lumen tube insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.