Anesthesia TimeNCT05791045
Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation
A study testing single vs double in people with Anesthesia Time, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Time
- What is being tested?
- single vs double
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 May 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 135 patients underwent bilateral ETSB procedure under general anesthesia
Who cannot join
- patients who underwent one sided ETSB
- patients under the age of 18
- Patients over 65 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation Study in Endoscopic Thoracic Sympathetic Blockade
In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade.
- Conditions
- Anesthesia Time
- Being tested
- single vs double
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single vs doubleProcedure or surgery
we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade
| Study group | Role | What they receive |
|---|---|---|
| double lumen tube | Active comparator | In the DLT group, the lung on the side to be treated was distinguished from the ventilator and extinguished and single lung ventilation was performed with the other lung. Receives: Procedure: single vs double |
| single lumen tube | Active comparator | In the SLT group, after thoracoscopic input, the anesthetist was in contact with the surgeon and his lung pressures were reduced manually until the lowest pressure, where the surgeon's vision was optimal. Receives: Procedure: single vs double |
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthesia time
anesthesia time during intubation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia TimeStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791045
- Sponsor's protocol ID
- Biruni HLM
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hashmonai M, Kopelman D. History of sympathetic surgery. Clin Auton Res. 2003 Dec;13 Suppl 1:I6-9. doi: 10.1007/s10286-003-1103-5.
PubMed 14673664Caso R, Kelly CH, Marshall MB. Single lumen endotracheal intubation with carbon dioxide insufflation for lung isolation in thoracic surgery. Surg Endosc. 2019 Oct;33(10):3287-3290. doi: 10.1007/s00464-018-06614-9. Epub 2018 Dec 3.
PubMed 30511311
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation Study in Endoscopic Thoracic Sympathetic Blockade
- ClinicalTrials.gov ID
- NCT05791045
- Acronym / sponsor ID
- Biruni HLM
- Conditions
- Anesthesia Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 30 Mar 2023 (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.
In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double lumen tube | Active comparator | Procedure: single vs doubleIn the DLT group, the lung on the side to be treated was distinguished from the ventilator and extinguished and single lung ventilation was performed with the other lung. |
| single lumen tube | Active comparator | Procedure: single vs doubleIn the SLT group, after thoracoscopic input, the anesthetist was in contact with the surgeon and his lung pressures were reduced manually until the lowest pressure, where the surgeon's vision was optimal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 135 patients underwent bilateral ETSB procedure under general anesthesia
Key exclusion criteria (3 listed)
- patients who underwent one sided ETSB
- patients under the age of 18
- Patients over 65 years of age
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 |
|---|---|---|
| single vs doublewe aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade | Procedure or surgery | double lumen tube, single lumen tube |
Primary outcome
anesthesia time
Time frame: 1 year
anesthesia time during intubation
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 30 Mar 2023.
- Background: PubMed 14673664Hashmonai M, Kopelman D. History of sympathetic surgery. Clin Auton Res. 2003 Dec;13 Suppl 1:I6-9. doi: 10.1007/s10286-003-1103-5.
- Results publication: PubMed 30511311Caso R, Kelly CH, Marshall MB. Single lumen endotracheal intubation with carbon dioxide insufflation for lung isolation in thoracic surgery. Surg Endosc. 2019 Oct;33(10):3287-3290. doi: 10.1007/s00464-018-06614-9. Epub 2018 Dec 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single vs double in people with Anesthesia Time, run by Biruni University at 1 site in Turkey (Türkiye).
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 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 30 Mar 2023. 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 Turkey (Türkiye). 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?
anesthesia time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791045, which also lists 2 linked publications.
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 30 Mar 2023.