Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding in Thryroidectomies

Thyroid Nodule Clinical Trial

Official title:

Comparison of the Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding Points in Thyroidectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547648
• Other study ID #: 172208
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: November 16, 2018

Study information

• Verified date: November 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA classification I-II patients

• Patients undergoing total thyroidectomy

• Aged between 18-60 years

Exclusion Criteria:

• Active pulmonary disease

• Cardiac aritmia

• Intracranial mass

• Coagulation defects

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Procedure:
• peak airway pressure
Patients' peak airway pressures will be raised to observe intraoperative bleeding in thyroidectomy surgery. Aim is to prevent postoperative bleeding.

Locations

Country	Name	City	State
Turkey	Turkey	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Tokaç M, Dumlu EG, Bozkurt B, Öcal H, Aydin C, Yalçin A, Çakir B, Kiliç 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative bleeding point	Determination of intraoperative bleeding point just after applying positive airway pressure manually	30 seconds
Secondary	postoperative haemorrhage	Postoperative haemorrhage for 24 hours postoperatively	24 hours