Perioperative Diaphragm Point of Care Ultrasound

NCT03688724 | Completed

• 1 other identifier: ROV-DPOCUS-2018-01
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

It is a prospective observational study of a cohort of patients who underwent brachial plexus blockage above the clavicle, and in which diaphragmatic function is observed in both hemidiaphragms by ultrasound (using Diaphragm Thickening Fraction), which allows to obtain the real incidence of Hemidiaphragm palsy in these patients, and estimate the perioperative evolution of both hemidiaphragms. Hemidiaphragm palsy after brachial plexus block above the clavicle (BPBAC) is frequent, but few patients develop postoperative pulmonary complications (PPC). Little attention has been paid to the contralateral hemidiaphragm as part of the global diaphragmatic function. After BPBAC, global diaphragm function reduces due to ipsilateral hemidiaphragm reduction, but less than expected due to the increase in the contralateral hemidiaphragm function. As a part of the diaphragm function, the contralateral hemidiaphragm function plays a relevant role in the appearance of PPC.

Conditions

Postoperative Pulmonary Complications; Diaphragm; Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• Contralateral Diaphragm function change

  Thickening fraction (%) change of contralateral hemidiaphragm Before-After Brachial plexus Block

  day of surgery (1 hour before surgery starts and 1 hour after surgery ends)

Secondary Outcomes (3)

• Ipsilateral Diaphragm function change

  day of surgery (1hour before surgery starts and 1hour after surgery ends)

• Incidence of Postoperative Pulmonary Complications

  postoperative 30 min after surgery at PACU(post anesthesia care unit)

• Incidence of contralateral hemidiaphragm increase after BPBAC.

  POSTOPERATIVE 30 min after surgery at PACU (post anesthesia care unit)

Eligibility Criteria

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

Study Population

Patients scheduled for upper limb surgery

You may qualify if:

• Patients scheduled for any type of surgery that requires a supraclavicular or interscalene block.

You may not qualify if:

• Age \<18 years
• No locoregional blockade over the clavicular for any reason, allergy to local anesthetics, coagulopathy, clinical reason.
• Rejection to enter the observational study

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, 46003, Spain

Location

Study Officials

• Lucas Rovira, PhD

  HGUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 28, 2018
• Study Start: October 15, 2018
• Primary Completion: March 5, 2021
• Study Completion: May 1, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

ES (1)