NCT06348745

Brief Summary

  • Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
  • Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
  • Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

February 28, 2024

Last Update Submit

April 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • diaphragmatic function

    Compare diaphragmatic function using ultrasound device by measuring diaphragmatic thickness in both stable COPD and bronchial asthma patients.

    2 years

Secondary Outcomes (1)

  • pulmonary function .

    2 years

Study Arms (2)

chronic obstructive pulmonary disease (COPD)

EXPERIMENTAL

ultrasound to COPD patients to asses' diaphragmatic function.

Device: ultrasound

bronchial asthma

EXPERIMENTAL

ultrasound to bronchial asthma patients to asses' diaphragmatic function.

Device: ultrasound

Interventions

5\. Transthoracic ultrasound for both right and left diaphragm during inspiration and expiration.

bronchial asthmachronic obstructive pulmonary disease (COPD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable patients (not in exacerbation).

You may not qualify if:

  • Patients with comorbidities as cardiac, renal or hepatic diseases.
  • Patients who have combined COPD and bronchial asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 28, 2024

First Posted

April 5, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share