NCT03547648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

May 23, 2018

Last Update Submit

November 18, 2018

Conditions

Thyroid NeoplasmsThyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • Intraoperative bleeding point

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

    30 seconds

Secondary Outcomes (1)

  • postoperative haemorrhage

    24 hours

Study Arms (3)

Group I ( 30 cm H2O)

ACTIVE COMPARATOR

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

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

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

Procedure: peak airway pressure

Interventions

peak airway pressurePROCEDURE

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

Group I ( 30 cm H2O)Group II( 40 cm H2O)Group III(50 cm H2O)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA classification I-II patients
  • Patients undergoing total thyroidectomy
  • Aged between 18-60 years

You may not qualify if:

  • Active pulmonary disease
  • Cardiac aritmia
  • Intracranial mass
  • Coagulation defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 29368315BACKGROUND

  • 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.

    PMID: 26414819RESULT

  • 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.

    PMID: 32276609DERIVED

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Murat Akcivan, resident

    Istanbul University

    STUDY CHAIR

  • Aylin Özdilek, MD

    Istanbul University

    STUDY CHAIR

  • Emre Erbabacan, Ass Prof

    Istanbul University

    STUDY CHAIR

  • Fatiş Altındaş, Prof

    Istanbul University

    STUDY CHAIR

  • Serkan Teksöz, Ass Prof

    Istanbul University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthesiologist

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 6, 2018

Study Start

June 15, 2018

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)