Cardiac SurgeryNCT04928521

Erector Spinae Plane (ESP) Block With 20 ml Versus 30 ml in Cardiac Surgery

A study testing bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine and bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine in people with Cardiac Surgery and Postoperative Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cardiac Surgery, Postoperative Pain
What is being tested?: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine and bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2021to 1 Oct 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

Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

Who cannot join

Emergency surgeries
Patients with allergic reactions to anesthesia and analgesia drugs to be used
Patients who do not want to participate in the study voluntarily
Severe systemic disease (kidney, liver, pulmonary, endocrine)
Substance abuse history
History of chronic pain

Show all 9Show fewer

Psychiatric problems and communication difficulties
Patients who need revision due to hemostasis in the postoperative period
Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara City Hospital
Ankara, Select State/Province, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery

Even though erector spinae plane (ESP) block is shown to be efficient in cardiac surgery, it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to investigate the optimal local anesthetic volume (20 mL versus 30 mL) with ESP block for open-heart cardiac surgery.

Read the detailed description

In cardiac surgery, the most common cause of pain during the first two days postoperatively is median sternotomy. In a study in which 705 patients who had undergone cardiac surgery were followed up prospectively, postoperative 24 hours pain scores ranging from 5.3 to 6.5 out of 10 with deep breathing and coughing were shown. In these patients, it may increase the frequency of atelectasis due to reasons such as failure in pain control, weak coughing, and limitation of movement, and these may lead increase in morbidity and hospital stay. Although nonsteroidal analgesics and opioids are used successfully in the control of this severe pain, they are far from being ideal analgesics alone due to their side effects such as kidney damage, bleeding risk, sedation, respiratory depression, itching, nausea, and vomiting. The complications of neuraxial techniques seem to be the disadvantages of these methods. Erector spinae plane (ESP) block is one of the regional anesthesia techniques that has been shown to be effective in reducing sternotomy pain in sternotomy-guided cardiac surgeries.

The Erector spinae plane (ESP) block was first described by Forero in 2016. In this block technique, a local anesthetic is given to the plane between the erector spinae muscle and the vertebral transverse process. The dorsal and ventral branches of the spinal nerves are blocked in this plane. However, due to individual regional anatomical differences, there is not enough data to determine the optimum volume at which the appropriate spread of local anesthetic will occur. Volume-based cadaver studies have some handicaps since they do not have the characteristics of living tissue.

This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy.

Conditions: Cardiac Surgery, Postoperative Pain
Being tested: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine, bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine
Keywords: erector spinae plane block, local anesthetic volume, bupivacaine, sternotomy
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bilateral erector spinae plane block with 30 mL 0.25 % bupivacaineProcedure or surgery
Also called 30 mL
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
bilateral erector spinae plane block with 20 mL 0.25 % bupivacaineProcedure or surgery
Also called 20 mL
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 20 mL 0.25 % bupivacaine

Study groups in NCT04928521
Study group	Role	What they receive
ESP block with 20 mL local anesthetic solution	Active comparator	An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 20 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation. Receives: Procedure: bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine
ESP block with 30 mL local anesthetic solution	Active comparator	An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 30 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation. Receives: Procedure: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-extubation 1st hour measurement
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Measured: 1 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 1st hour measurement
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Measured: 1 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 1st hour measurement
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Measured: 1 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 2nd hour measurement
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Measured: 2 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 2nd hour measurement
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Measured: 2 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 2nd hour measurement
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Measured: 2 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 4th hour measurement
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Measured: 4 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 4th hour measurement
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Measured: 4 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 4th hour measurement
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Measured: 4 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 8th hour measurement
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Measured: 8 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 8th hour measurement
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Measured: 8 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 8th hour measurement
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Measured: 8 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 12th hour measurement
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Measured: 12 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 12th hour measurement
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Measured: 12 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 12th hour measurement
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Measured: 12 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 24th hour measurement
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Measured: 24 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 24th hour measurement
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Measured: 24 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 24th hour measurement
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Measured: 24 hour after endotracheal extubation, an average of 5 minutes

Secondary outcomes (2)

Mechanical ventilation duration
The total time until patients suitable for endotracheal extubation
Measured: postoperative, approximately 4 to 10 hours
intensive care unit duration
The total time until patients suitable for discharge from intensive care unit
Measured: postoperative, approximately 12 to 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20211 Oct 2021

First posted16 Jun 2021
Study start1 Jun 2021
Primary completion1 Aug 2021
Study completion1 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
More trials run by Ankara City Hospital BilkentThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04928521
Sponsor's protocol ID: MH2.3
Status last verified: Dec 2021
First submitted: 6 Jun 2021
Last updated: 28 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
PubMed 10936130
Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
PubMed 15043239
Cheng DC, Wall C, Djaiani G, Peragallo RA, Carroll J, Li C, Naylor D. Randomized assessment of resource use in fast-track cardiac surgery 1-year after hospital discharge. Anesthesiology. 2003 Mar;98(3):651-7. doi: 10.1097/00000542-200303000-00013.
PubMed 12606909
Silbert BS, Santamaria JD, Kelly WJ, O'brien JL, Blyth CM, Wong MY, Allen NB; Fast Track Cardiac Care Team. Early extubation after cardiac surgery: emotional status in the early postoperative period. J Cardiothorac Vasc Anesth. 2001 Aug;15(4):439-44. doi: 10.1053/jcan.2001.24978.
PubMed 11505346
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery
ClinicalTrials.gov ID: NCT04928521
Acronym / sponsor ID: MH2.3
Conditions: Cardiac Surgery, Postoperative Pain
Keywords: erector spinae plane block, local anesthetic volume, bupivacaine, sternotomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Ankara City Hospital BilkentUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 1 Oct 2021 (actual)
First posted: 16 Jun 2021 (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.

Detailed description

This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ESP block with 20 mL local anesthetic solution	Active comparator	Procedure: bilateral erector spinae plane block with 20 mL 0.25 % bupivacaineAn erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 20 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation.
ESP block with 30 mL local anesthetic solution	Active comparator	Procedure: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaineAn erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 30 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

Key exclusion criteria (9 listed)

Emergency surgeries
Patients with allergic reactions to anesthesia and analgesia drugs to be used
Patients who do not want to participate in the study voluntarily
Severe systemic disease (kidney, liver, pulmonary, endocrine)
Substance abuse history

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
bilateral erector spinae plane block with 30 mL 0.25 % bupivacaineAlso: 30 mLPreoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine	Procedure or surgery	ESP block with 30 mL local anesthetic solution
bilateral erector spinae plane block with 20 mL 0.25 % bupivacaineAlso: 20 mLPreoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 20 mL 0.25 % bupivacaine	Procedure or surgery	ESP block with 20 mL local anesthetic solution

Primary outcome

Post-extubation 1st hour measurement
Time frame: 1 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 1st hour measurement
Time frame: 1 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Post-extubation 1st hour measurement
Time frame: 1 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Post-extubation 2nd hour measurement
Time frame: 2 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 2nd hour measurement
Time frame: 2 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Post-extubation 2nd hour measurement
Time frame: 2 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Post-extubation 4th hour measurement
Time frame: 4 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 4th hour measurement
Time frame: 4 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Post-extubation 4th hour measurement
Time frame: 4 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Post-extubation 8th hour measurement
Time frame: 8 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 8th hour measurement
Time frame: 8 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Post-extubation 8th hour measurement
Time frame: 8 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Post-extubation 12th hour measurement
Time frame: 12 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 12th hour measurement
Time frame: 12 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Post-extubation 12th hour measurement
Time frame: 12 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.
Post-extubation 24th hour measurement
Time frame: 24 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.
Post-extubation 24th hour measurement
Time frame: 24 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.
Post-extubation 24th hour measurement
Time frame: 24 hour after endotracheal extubation, an average of 5 minutes
patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

2 secondary outcomes

Mechanical ventilation duration
Time frame: postoperative, approximately 4 to 10 hours
intensive care unit duration
Time frame: postoperative, approximately 12 to 36 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 28 Dec 2021.
Background: PubMed 10936130Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
Background: PubMed 15043239Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
Background: PubMed 12606909Cheng DC, Wall C, Djaiani G, Peragallo RA, Carroll J, Li C, Naylor D. Randomized assessment of resource use in fast-track cardiac surgery 1-year after hospital discharge. Anesthesiology. 2003 Mar;98(3):651-7. doi: 10.1097/00000542-200303000-00013.
Background: PubMed 11505346Silbert BS, Santamaria JD, Kelly WJ, O'brien JL, Blyth CM, Wong MY, Allen NB; Fast Track Cardiac Care Team. Early extubation after cardiac surgery: emotional status in the early postoperative period. J Cardiothorac Vasc Anesth. 2001 Aug;15(4):439-44. doi: 10.1053/jcan.2001.24978.
Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

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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.

ZELİHA A DEMİR principal investigator

Ankara City Hospital Bilkent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 28 Dec 2021. 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?

Post-extubation 1st hour measurement (time frame: 1 hour after endotracheal extubation, an average of 5 minutes). The study lists 18 primary outcomes in all. 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 NCT04928521, which also lists 5 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 28 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.