Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery

Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery: Prospective Observational Study

In children undergoing pulmonary resection, the diaphragm function is evaluated using ultrasound before and after surgery to evaluate the incidence of diaphragm dysfunction after pulmonary resection. In addition, we examine if there is a relationship between diaphragmatic dysfunction and pulmonary complications, including postoperative lung atelectasis.

Study Overview

• Status: Completed
• Conditions: Diaphragm Dysfunction
• Intervention / Treatment: Device: Diaphragm ultrasound

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients under 7 years undergoing lung resection

Description

Inclusion Criteria:

• Pediatric patients under 7 years undergoing lung resection

Exclusion Criteria:

• Asthma
• Myopathy or neuropathy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients undergoing lung resection	Device: Diaphragm ultrasound; Diaphragm ultrasound is performed at the following three time points.; At the entrance of the operating room before induction of anesthesia; 1 hour after surgery; 24 hours after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diaphragmatic thickness	Changes in diaphragmatic thickness, from time frame 1 to 3	1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Changes in diaphragm thickening fraction	Changes in diaphragm thickening fraction, from time frame 1 to 3	1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Changes in the length of diaphragmatic tidal excursion	Changes in the length of diaphragmatic tidal excursion, from time frame 1 to 3	1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: diaphragm_US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No