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

Primary Purpose

Thyroid Neoplasms, Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
peak airway pressure
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Neoplasms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Turkey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group I ( 30 cm H2O)

Group II( 40 cm H2O)

Group III(50 cm H2O)

Arm Description

Patients will be applied 30 cm H2O peak airway pressure manually at the end of the surgery

Patients will be applied 40 cm H2O peak airway pressure manually at the end of the surgery

Patients will be applied 50 cm H2O peak airway pressure manually at the end of the surgery

Outcomes

Primary Outcome Measures

Intraoperative bleeding point
Determination of intraoperative bleeding point just after applying positive airway pressure manually

Secondary Outcome Measures

postoperative haemorrhage
Postoperative haemorrhage for 24 hours postoperatively

Full Information

First Posted
May 23, 2018
Last Updated
November 18, 2018
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03547648
Brief Title
Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding in Thryroidectomies
Official Title
Comparison of the Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding Points in Thyroidectomies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms, Thyroid Nodule

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I ( 30 cm H2O)
Arm Type
Active Comparator
Arm Description
Patients will be applied 30 cm H2O peak airway pressure manually at the end of the surgery
Arm Title
Group II( 40 cm H2O)
Arm Type
Active Comparator
Arm Description
Patients will be applied 40 cm H2O peak airway pressure manually at the end of the surgery
Arm Title
Group III(50 cm H2O)
Arm Type
Active Comparator
Arm Description
Patients will be applied 50 cm H2O peak airway pressure manually at the end of the surgery
Intervention Type
Procedure
Intervention Name(s)
peak airway pressure
Intervention Description
Patients' peak airway pressures will be raised to observe intraoperative bleeding in thyroidectomy surgery. Aim is to prevent postoperative bleeding.
Primary Outcome Measure Information:
Title
Intraoperative bleeding point
Description
Determination of intraoperative bleeding point just after applying positive airway pressure manually
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
postoperative haemorrhage
Description
Postoperative haemorrhage for 24 hours postoperatively
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Akcivan, resident
Organizational Affiliation
Istanbul University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aylin Özdilek, MD
Organizational Affiliation
Istanbul University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emre Erbabacan, Ass Prof
Organizational Affiliation
Istanbul University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatiş Altındaş, Prof
Organizational Affiliation
Istanbul University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Serkan Teksöz, Ass Prof
Organizational Affiliation
Istanbul University
Official's Role
Study Chair
Facility Information:
Facility Name
Turkey
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29368315
Citation
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.
Results Reference
background
PubMed Identifier
26414819
Citation
Tokac 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.
Results Reference
result
PubMed Identifier
32276609
Citation
Beyoglu 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.
Results Reference
derived

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

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