Valsalva Maneuver in Thyroidectomy

July 26, 2022 updated by: Mario Pacilli, University of Foggia

Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy

Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.

Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.

The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Foggia, Italy, 71122
        • Policlinico di Foggia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients underwent total thyroidectomy

Description

Inclusion Criteria:

  • thyroid diseases

Exclusion Criteria:

  • lymph node dissection
  • minimally invasive approaches
  • high anesthesiological risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GROUP A-NO Valsalva maneuver
GROUP B- Valsalva maneuver
Procedure: Valsalva maneuver
Valsalva maneuver: increase intrabdominal pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of cervical drainage after total thyroidectomy
Time Frame: 24 hours
Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)
24 hours
Number of reinterventions
Time Frame: 24 hours
Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Foggia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

April 10, 2022

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (ACTUAL)

July 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFoggia2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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