Thoracic SurgeryNCT04373174
The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery
A study testing Regional oximetry probe and Thoracic Epidural block in people with Thoracic Surgery and Epidural Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Today, it is preferred that the lung with pathology for thorax surgery is not under ventilation during operation in terms of reliability and ease of operation. For this reason, the anesthesia approach is characteristic and it is ensured that the single lung is not ventilated during the operation by means of specially… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Surgery, Epidural Anesthesia, Cerebral Oxygen Saturation
- What is being tested?
- Regional oximetry probe and Thoracic Epidural block
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 15 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
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent Thoracic Surgery
Who cannot join
- Local anesthetic allergy,
- Bleeding is a diathesis disorder
- Allergic to the drugs used,
- Patients who are not reluctant to participate in the study,
- Presence of infection in the block area,
- Patients whose body mass index is over 30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery Operations Where Single Lung Ventilation is Applied
Today, it is preferred that the lung with pathology for thorax surgery is not under ventilation during operation in terms of reliability and ease of operation.
For this reason, the anesthesia approach is characteristic and it is ensured that the single lung is not ventilated during the operation by means of specially manufactured intubation tubes. This application can disrupt tissue oxygenation due to both Operation position and single lung ventilation.
Thoracic epidural analgesia, which is applied as the gold standard of Thoracic Surgery, is applied prior to the operation and is provided to assist in postoperative analgesia.
Read the detailed description
The aim of this study was to investigate the effect of thoracic epidural analgesia method on brain tissue oxygenation in patients with single lung ventilation.
- Being tested
- Regional oximetry probe, Thoracic Epidural block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional oximetry probeDevice
Regional oximetry probe will be placed in the frontal area of the head
Thoracic Epidural blockProcedure or surgery
Thoracic epidural block will be applied to the patients before the operation begins
| Study group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | Thoracic Epidural block + Regional oximetry probe will be placed in the frontal area of the head Receives: Device: Regional oximetry probe; Procedure: Thoracic Epidural block |
| Group P | Sham comparator | Regional oximetry probe will be placed in the frontal area of the head Receives: Device: Regional oximetry probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
rso2
Regional oximetry probe will be placed in the frontal area of the head
Measured: peroperative 2 hours
Secondary outcomes (2)
po2
Arterial blood gas oxygen pressure
Measured: peroperative 2 hours
ETCO2
End-tidal carbon dioxide (ETCO2) level
Measured: peroperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 May 2020
- Primary completion1 Apr 2021
- Study completion15 May 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective,randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Assoc. PhD., Study director, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373174
- Sponsor's protocol ID
- BYIERH
- Status last verified
- Jan 2023
- First submitted
- 30 Apr 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery Operations Where Single Lung Ventilation is Applied
- ClinicalTrials.gov ID
- NCT04373174
- Acronym / sponsor ID
- BYIERH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 4 May 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.
Today, it is preferred that the lung with pathology for thorax surgery is not under ventilation during operation in terms of reliability and ease of operation.
For this reason, the anesthesia approach is characteristic and it is ensured that the single lung is not ventilated during the operation by means of specially manufactured intubation tubes. This application can disrupt tissue oxygenation due to both Operation position and single lung ventilation.
Thoracic epidural analgesia, which is applied as the gold standard of Thoracic Surgery, is applied prior to the operation and is provided to assist in postoperative analgesia.
Detailed description
The aim of this study was to investigate the effect of thoracic epidural analgesia method on brain tissue oxygenation in patients with single lung ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective,randomized
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Device: Regional oximetry probe, Procedure: Thoracic Epidural blockThoracic Epidural block + Regional oximetry probe will be placed in the frontal area of the head |
| Group P | Sham comparator | Device: Regional oximetry probeRegional oximetry probe will be placed in the frontal area of the head |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent Thoracic Surgery
Key exclusion criteria (6 listed)
- Local anesthetic allergy,
- Bleeding is a diathesis disorder
- Allergic to the drugs used,
- Patients who are not reluctant to participate in the study,
- Presence of infection in the block area,
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 |
|---|---|---|
| Regional oximetry probeRegional oximetry probe will be placed in the frontal area of the head | Device | Group E, Group P |
| Thoracic Epidural blockThoracic epidural block will be applied to the patients before the operation begins | Procedure or surgery | Group E |
Primary outcome
rso2
Time frame: peroperative 2 hours
Regional oximetry probe will be placed in the frontal area of the head
2 secondary outcomes
po2
Time frame: peroperative 2 hours
ETCO2
Time frame: peroperative 2 hours
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 10 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Korgün Ökmen, Assoc. PhD. study director
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional oximetry probe and Thoracic Epidural block in people with Thoracic Surgery and Epidural Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 2 inclusion and 6 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 10 Jan 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. Some participants in this study may receive a placebo. 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?
rso2 (time frame: peroperative 2 hours). 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 Jan 2023.