Diaphragm DysfunctionNCT04400370
Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery
An observational study of Diaphragm Dysfunction, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Diaphragm Dysfunction
- What is being tested?
- Diaphragm ultrasound
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Child
Study population: Pediatric patients under 7 years undergoing lung resection
Who may be able to join
- Pediatric patients under 7 years undergoing lung resection
Who cannot join
- Asthma
- Myopathy or neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diaphragm Dysfunction
- Being tested
- Diaphragm ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm ultrasoundDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients undergoing lung resection | Not described Receives: Device: Diaphragm ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diaphragmatic thickness
Changes in diaphragmatic thickness, from time frame 1 to 3
Measured: 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
Measured: 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
Measured: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start8 Jun 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm DysfunctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400370
- Sponsor's protocol ID
- diaphragm_US
- Status last verified
- Mar 2023
- First submitted
- 6 May 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37823729
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04400370
- Acronym / sponsor ID
- diaphragm_US
- Conditions
- Diaphragm Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients undergoing lung resection | – | Device: Diaphragm ultrasound |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients under 7 years undergoing lung resection
Key inclusion criteria (1 listed)
- Pediatric patients under 7 years undergoing lung resection
Key exclusion criteria (2 listed)
- Asthma
- Myopathy or neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm ultrasoundDiaphragm 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 | Device | Pediatric patients undergoing lung resection |
Primary outcome
Changes in diaphragmatic thickness
Time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Changes in diaphragmatic thickness, from time frame 1 to 3
Changes in diaphragm thickening fraction
Time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Changes in diaphragm thickening fraction, from time frame 1 to 3
Changes in the length of diaphragmatic tidal excursion
Time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
Changes in the length of diaphragmatic tidal excursion, from time frame 1 to 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 37823729Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Dysfunction, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in diaphragmatic thickness (time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.