NCT04400370

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

May 6, 2020

Last Update Submit

March 1, 2023

Conditions

Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Pediatric patients undergoing lung resection

Device: Diaphragm ultrasound

Interventions

Diaphragm ultrasoundDEVICE

Diaphragm ultrasound is performed at the following three time points. 1. At the entrance of the operating room before induction of anesthesia 2. 1 hour after surgery 3. 24 hours after surgery

Pediatric patients undergoing lung resection

Eligibility Criteria

AgeUp to 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric patients under 7 years undergoing lung resection

You may qualify if:

  • Pediatric patients under 7 years undergoing lung resection

You may not qualify if:

  • Asthma
  • Myopathy or neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

  • Lee JH, Kang P, Park JB, Kim JT. Changes in diaphragmatic ultrasonography findings and their association with postoperative complications in children undergoing pulmonary resection: A single-centre, prospective, observational study. Eur J Anaesthesiol. 2023 Dec 1;40(12):953-956. doi: 10.1097/EJA.0000000000001910. Epub 2023 Oct 12.

    PMID: 37823729DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 22, 2020

Study Start

June 8, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

KR(1)