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NCT04400370 Clinical Trial

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

Diaphragm Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04400370
Other study ID # diaphragm_US
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2020
Est. completion date May 1, 2022

Study information
Verified date March 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers
Gender All
Age group N/A to 6 Years
Eligibility Inclusion Criteria: - Pediatric patients under 7 years undergoing lung resection Exclusion Criteria: - Asthma - Myopathy or neuropathy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Jin-Tae Kim Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
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Completed NCT03852394 - Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed NIV (RHYDIAN)
Recruiting NCT02900300 - A Biobank for Diaphragm Muscular Fiber
Not yet recruiting NCT05953649 - Effect of Early Extracorporeal Diaphragm Pacing Combined With Tilt Table in Ventilated Patients. N/A