Thoracic AnesthesiaNCT04449770
Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy
An observational study of Thoracic Anesthesia, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The use of height based formula to predict insertion depth of left-sided double lumen tube in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Anesthesia
- What is being tested?
- double lumen tube
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Aug 2020to Jun 2022
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult patients aged 20-60 yr undergoing thoracic surgery with the use of left-sided DLT for lung isolation
Who may be able to join
- patients whose procedure required placement of an LDLT
Who cannot join
- patients with intraluminal bronchial lesions and patients with a difficult airway.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud University
Riyadh, 11462
abdelazeem eldawlatly, 966503261042 ext. 966503261042, dawlatly2@yahoo.com
About this study
Official title: A Study on the Use of an Established Novel Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy
The use of height based formula to predict insertion depth of left-sided double lumen tube in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study we are going to use with FOB checking if needed.
Read the detailed description
The use of a height-based formula to predict the insertion depth of left-sided double-lumen tubes in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study will use FOB checking if needed.
Our hypothesis is that DLT can insert without the use of FOB in most of the cases. That doesn't mean FOB is less required.
- Conditions
- Thoracic Anesthesia
- Being tested
- double lumen tube
- Keywords
- Thoracic anesthesia, Double lumen tube, Height based formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double lumen tubeDevice
prospective cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
correct position of DLT with proper lung deflation without use of FOB
proper lung deflation, surgeon satisfaction
Measured: during surgical time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study startAug 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.Eldawlatly, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449770
- Sponsor's protocol ID
- E-18-3064/IRB 06.05.2018
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Use of an Established Novel Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT04449770
- Acronym / sponsor ID
- E-18-3064/IRB 06.05.2018
- Conditions
- Thoracic Anesthesia
- Keywords
- Thoracic anesthesia, Double lumen tube, Height based formula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 Jun 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 use of height based formula to predict insertion depth of left-sided double lumen tube in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study we are going to use with FOB checking if needed.
Detailed description
The use of a height-based formula to predict the insertion depth of left-sided double-lumen tubes in thoracic surgery is now well established. The investigators have developed a formula to be used and published recently. The investigators verified the formula with the use of FOB. This observational study will use FOB checking if needed.
Our hypothesis is that DLT can insert without the use of FOB in most of the cases. That doesn't mean FOB is less required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult patients aged 20-60 yr undergoing thoracic surgery with the use of left-sided DLT for lung isolation
Key inclusion criteria (1 listed)
- patients whose procedure required placement of an LDLT
Key exclusion criteria (1 listed)
- patients with intraluminal bronchial lesions and patients with a difficult airway.
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 |
|---|---|---|
| double lumen tubeprospective cohort study | Device | – |
Primary outcome
correct position of DLT with proper lung deflation without use of FOB
Time frame: during surgical time
proper lung deflation, surgeon satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Anesthesia, run by King Saud 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelazeem eldawlatly (00966503261042, dawlatly2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correct position of DLT with proper lung deflation without use of FOB (time frame: during surgical time). 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 10 Jul 2020.