Thyroid NeoplasmsNCT03547648
Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding in Thryroidectomies
A study testing peak airway pressure in people with Thyroid Neoplasms and Thyroid Nodule, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing thyroidectomy will be divided into three groups (30 cm H2O Group I, 40 cm H2O Group II, 50 cmH2O Group III). At the end of the operation patients will be applied peak airway pressure manually according to involved groups.The time until the first hemorrhage is seen in each group or if not seen… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Neoplasms, Thyroid Nodule
- What is being tested?
- peak airway pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 16 Nov 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA classification I-II patients
- Patients undergoing total thyroidectomy
- Aged between 18-60 years
Who cannot join
- Active pulmonary disease
- Cardiac aritmia
- Intracranial mass
- Coagulation defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding Points in Thyroidectomies
Patients undergoing thyroidectomy will be divided into three groups (30 cm H2O Group I, 40 cm H2O Group II, 50 cmH2O Group III). At the end of the operation patients will be applied peak airway pressure manually according to involved groups.The time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be ended.We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure, postoperative haemorrhage that required surgery, and postoperative hematomas during peak airway pressure increase during the operation in all patients. The 1st hour blood pressure, nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery unit.
The primary end point of the study is intraoperative bleeding detected, and the secondary end point is postoperative bleeding.
Read the detailed description
Patients will be divided into three groups (https://www.randomizer.org/) by computer assisted randomization method (30 cm H2O in Group I, 40 cm H2O in Group II, 50 cmH2O in Group III peak pressure will be applied). The time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be ended.
Patients will be taken to the operation table and standard monitorization will be performed consisting of ECG, non-invasive blood pressure and peripheral O2 saturation from the back region. Anesthesia was induced with 2 mg / kg propofol (propofol 1% Fresenius, Fresenius Kabi, Germany), 2 mg / kg fentanyl (Talinat 0,5mg / 10ml, AND, Turkey), 0.6 mg / kg rocuronium (Muscuro 50mg / 5ml, Kocak Farma , Turkey) will be provided after the patients were intubated orally. General anesthesia treatment will be provided with 2% Sevoflurane in 40% oxygen-air mixture. All patients will be ventilated in pressure controlled mode; respiratory frequency: 12 / min, FiO2: 40% (oxygen-air mixture), I/E:1/2, PEEP: 7 cmH2O supplying end tidal CO2 value of 32-36 mmHg.
Calculating the ideal weight of the patient, isolated-S (Polifarma, Turkey)2ml/kg/h will be infused. If the systolic arterial pressure (SAB) or heart rate (HR) increases by 20% compared to baseline, IV 50 μg fentanyl will be administered. At the end of the operation, the patient's airway peak pressure will be increased before hemostasis is provided by the same surgeon (S.T.). Positive pressure on the Maquet Flow I device (Maquet Flow I-AGC, Rastatt, USA) will be applied manually(30 cm H2O in Group I, 40 cm H2O in Group II patients and 50 cm H2O in group III patients). The airway peak pressure increase will be maintained and recorded until the surgeon sees the first bleeding point or if not seen for 30 seconds. For all three groups this process will be repeated one more time.
After peak airway pressure is increased, the number of bleeding centers detected, how long time did it take to detect and the size of the bleeding vessel (<2 mm or> 2 mm)will be recorded. We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure, postoperative haemorrhage that required surgery, and postoperative hematomas during peak airway pressure increase during the operation in all patients. The 1st hour blood pressure, nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery unit.
The primary end point of the study is intraoperative bleeding detected, and w the secondary end point is postoperative bleeding.
- Conditions
- Thyroid Neoplasms, Thyroid Nodule
- Being tested
- peak airway pressure
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peak airway pressureProcedure or surgery
Patients' peak airway pressures will be raised to observe intraoperative bleeding in thyroidectomy surgery. Aim is to prevent postoperative bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Group I ( 30 cm H2O) | Active comparator | Patients will be applied 30 cm H2O peak airway pressure manually at the end of the surgery Receives: Procedure: peak airway pressure |
| Group II( 40 cm H2O) | Active comparator | Patients will be applied 40 cm H2O peak airway pressure manually at the end of the surgery Receives: Procedure: peak airway pressure |
| Group III(50 cm H2O) | Active comparator | Patients will be applied 50 cm H2O peak airway pressure manually at the end of the surgery Receives: Procedure: peak airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding point
Determination of intraoperative bleeding point just after applying positive airway pressure manually
Measured: 30 seconds
Secondary outcomes (1)
postoperative haemorrhage
Postoperative haemorrhage for 24 hours postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start15 Jun 2018
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Cigdem Akyol Beyoğlu, Istanbul University
- Investigators
- Murat Akcivan, resident, Study chair, Istanbul UniversityAylin Özdilek, MD, Study chair, Istanbul UniversityEmre Erbabacan, Ass Prof, Study chair, Istanbul UniversityFatiş Altındaş, Prof, Study chair, Istanbul UniversitySerkan Teksöz, Ass Prof, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547648
- Sponsor's protocol ID
- 172208
- Status last verified
- Nov 2018
- First submitted
- 23 May 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar CM, Van Zundert AAJ. Intraoperative Valsalva maneuver: a narrative review. Can J Anaesth. 2018 May;65(5):578-585. doi: 10.1007/s12630-018-1074-6. Epub 2018 Jan 24.
PubMed 29368315Tokac M, Dumlu EG, Bozkurt B, Ocal H, Aydin C, Yalcin A, Cakir B, Kilic M. Effect of Intraoperative Valsalva Maneuver Application on Bleeding Point Detection and Postoperative Drainage After Thyroidectomy Surgeries. Int Surg. 2015 Jun;100(6):994-8. doi: 10.9738/INTSURG-D-15-00002.1.
PubMed 26414819Beyoglu CA, Teksoz S, Ozdilek A, Akcivan M, Erbabacan E, Altindas F, Koksal G. A comparison of the efficacy of three different peak airway pressures on intraoperative bleeding point detection in patients undergoing thyroidectomy: a randomized, controlled, clinical trial. BMC Surg. 2020 Apr 10;20(1):69. doi: 10.1186/s12893-020-00728-5.
PubMed 32276609
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding Points in Thyroidectomies
- ClinicalTrials.gov ID
- NCT03547648
- Acronym / sponsor ID
- 172208
- Conditions
- Thyroid Neoplasms, Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 6 Jun 2018 (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.
Patients undergoing thyroidectomy will be divided into three groups (30 cm H2O Group I, 40 cm H2O Group II, 50 cmH2O Group III). At the end of the operation patients will be applied peak airway pressure manually according to involved groups.The time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be ended.We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure, postoperative haemorrhage that required surgery, and postoperative hematomas during peak airway pressure increase during the operation in all patients. The 1st hour blood pressure, nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery unit.
The primary end point of the study is intraoperative bleeding detected, and the secondary end point is postoperative bleeding.
Detailed description
Patients will be divided into three groups (https://www.randomizer.org/) by computer assisted randomization method (30 cm H2O in Group I, 40 cm H2O in Group II, 50 cmH2O in Group III peak pressure will be applied). The time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be ended.
Patients will be taken to the operation table and standard monitorization will be performed consisting of ECG, non-invasive blood pressure and peripheral O2 saturation from the back region. Anesthesia was induced with 2 mg / kg propofol (propofol 1% Fresenius, Fresenius Kabi, Germany), 2 mg / kg fentanyl (Talinat 0,5mg / 10ml, AND, Turkey), 0.6 mg / kg rocuronium (Muscuro 50mg / 5ml, Kocak Farma , Turkey) will be provided after the patients were intubated orally. General anesthesia treatment will be provided with 2% Sevoflurane in 40% oxygen-air mixture. All patients will be ventilated in pressure controlled mode; respiratory frequency: 12 / min, FiO2: 40% (oxygen-air mixture), I/E:1/2, PEEP: 7 cmH2O supplying end tidal CO2 value of 32-36 mmHg.
Calculating the ideal weight of the patient, isolated-S (Polifarma, Turkey)2ml/kg/h will be infused. If the systolic arterial pressure (SAB) or heart rate (HR) increases by 20% compared to baseline, IV 50 μg fentanyl will be administered. At the end of the operation, the patient's airway peak pressure will be increased before hemostasis is provided by the same surgeon (S.T.). Positive pressure on the Maquet Flow I device (Maquet Flow I-AGC, Rastatt, USA) will be applied manually(30 cm H2O in Group I, 40 cm H2O in Group II patients and 50 cm H2O in group III patients). The airway peak pressure increase will be maintained and recorded until the surgeon sees the first bleeding point or if not seen for 30 seconds. For all three groups this process will be repeated one more time.
After peak airway pressure is increased, the number of bleeding centers detected, how long time did it take to detect and the size of the bleeding vessel (<2 mm or> 2 mm)will be recorded. We will record the blood pressure, spO2, HR, the first ETCO2 after the procedure, postoperative haemorrhage that required surgery, and postoperative hematomas during peak airway pressure increase during the operation in all patients. The 1st hour blood pressure, nausea-vomiting score and pain score (NRS) will be recorded in the postoperative recovery unit.
The primary end point of the study is intraoperative bleeding detected, and w the secondary end point is postoperative bleeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I ( 30 cm H2O) | Active comparator | Procedure: peak airway pressurePatients will be applied 30 cm H2O peak airway pressure manually at the end of the surgery |
| Group II( 40 cm H2O) | Active comparator | Procedure: peak airway pressurePatients will be applied 40 cm H2O peak airway pressure manually at the end of the surgery |
| Group III(50 cm H2O) | Active comparator | Procedure: peak airway pressurePatients will be applied 50 cm H2O peak airway pressure manually at the end of the surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA classification I-II patients
- Patients undergoing total thyroidectomy
- Aged between 18-60 years
Key exclusion criteria (4 listed)
- Active pulmonary disease
- Cardiac aritmia
- Intracranial mass
- Coagulation defects
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 |
|---|---|---|
| peak airway pressurePatients' peak airway pressures will be raised to observe intraoperative bleeding in thyroidectomy surgery. Aim is to prevent postoperative bleeding. | Procedure or surgery | Group I ( 30 cm H2O), Group II( 40 cm H2O), Group III(50 cm H2O) |
Primary outcome
Intraoperative bleeding point
Time frame: 30 seconds
Determination of intraoperative bleeding point just after applying positive airway pressure manually
1 secondary outcome
postoperative haemorrhage
Time frame: 24 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 20 Nov 2018.
- Background: PubMed 29368315Kumar CM, Van Zundert AAJ. Intraoperative Valsalva maneuver: a narrative review. Can J Anaesth. 2018 May;65(5):578-585. doi: 10.1007/s12630-018-1074-6. Epub 2018 Jan 24.
- Results publication: PubMed 26414819Tokac M, Dumlu EG, Bozkurt B, Ocal H, Aydin C, Yalcin A, Cakir B, Kilic M. Effect of Intraoperative Valsalva Maneuver Application on Bleeding Point Detection and Postoperative Drainage After Thyroidectomy Surgeries. Int Surg. 2015 Jun;100(6):994-8. doi: 10.9738/INTSURG-D-15-00002.1.
- Derived from this study: PubMed 32276609Beyoglu CA, Teksoz S, Ozdilek A, Akcivan M, Erbabacan E, Altindas F, Koksal G. A comparison of the efficacy of three different peak airway pressures on intraoperative bleeding point detection in patients undergoing thyroidectomy: a randomized, controlled, clinical trial. BMC Surg. 2020 Apr 10;20(1):69. doi: 10.1186/s12893-020-00728-5.
- 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.
Murat Akcivan, resident study chair
Istanbul University
Aylin Özdilek, MD study chair
Istanbul University
Emre Erbabacan, Ass Prof study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peak airway pressure in people with Thyroid Neoplasms and Thyroid Nodule, run by Istanbul 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 3 inclusion and 4 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 20 Nov 2018. 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?
Intraoperative bleeding point (time frame: 30 seconds). 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 NCT03547648, which also lists 3 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 20 Nov 2018.