Valsalva Maneuver in Thyroidectomy

NCT05474261 | Completed

• 1 other identifier: UFoggia2
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding

Outcome Measures

Primary Outcomes (2)

• Volume of cervical drainage after total thyroidectomy

  Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)

  24 hours

• Number of reinterventions

  Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.

  24 hours

Study Arms (2)

GROUP A-NO Valsalva maneuver

GROUP B- Valsalva maneuver

Procedure: Valsalva maneuver

Interventions

Valsalva maneuver PROCEDURE

Valsalva maneuver: increase intrabdominal pressure

GROUP B- Valsalva maneuver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients underwent total thyroidectomy

You may qualify if:

• thyroid diseases

You may not qualify if:

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

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Policlinico Di Foggia

Foggia, 71122, Italy

Location

MeSH Terms

Interventions

Valsalva Maneuver

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: January 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: April 10, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

IT (1)