Lung Ultrasound for Acute Respiratory Infections by Community Health Workers

NCT03594383 | Completed DMC

• 1 other identifier: 5106-Ped-ERC-17
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

The specific objectives focus on using a train-the-trainer model to educate CHWs in Pakistan on performing and interpreting pediatric lung POCUS. In the first phase, the POCUS experts from Toronto will rigorously train the first generation of local lung POCUS users who are Pakistani health care providers to become local lung POCUS trainers. These first generation trainers will subsequently collaborate with the POCUS experts from Toronto to develop a two-day training program for lung POCUS image interpretation and acquisition that is tailored to novice users (CHWs) in low-resource settings. In the second phase, the first generation local lung POCUS trainers will deliver and evaluate the new training program to the second generation of users - a group of CHWs in Karachi. In the third phase, we will establish the reliability of CHWs to perform lung POCUS on pediatric patients with respiratory symptoms, upon completion of the training program developed by local trainers.

Conditions

Child; Pneumonia

Keywords

Lung; POCUS; Pneumonia; ARI; CHWs

Outcome Measures

Primary Outcomes (1)

• primary outcome of interest will be the inter-rater reliability of lung POCUS findings (on a cohort of patients at AKUH with ARI) between the newly trained CHWs and a local lung POCUS trainer.

  Proportion of CHWs undergoing training in lung POCUS with a passing score 80% in a computer-based test (consisting of 60 lung POCUS video clips) with questions to determine their image interpretation skills as a reflection of technical performance. On completion of training program, they will perform lung POCUS on pediatric patients presenting to Aga Khan University Hospital (AKUH) with respiratory symptoms. For primary outcome of inter-rater reliability, the Cohen's kappa statistic will be calculated using standardized formulas. in the end will be describing the kappa statistic between final interpretations (overall and for each lung zone) of each scan by the CHWs as compared to the POCUS expert.

  12 months

Secondary Outcomes (3)

• Train the trainer

  20 days

• Train novice users

  2 days

• Reliability of CHW lung POCUS use on children with acute respiratory illnesses

  6 months

Interventions

ULTRASOUND DEVICE

Lung ultrasound done through POCUS to diagnose pneumonia

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between age of 2 months to 5 years and presenting with signs and symptoms of pneumonia, will be identified and approached by clinical team members in the AKUH emergency department, outpatient clinic and pediatric ward. The research member will review the study with the family and obtain informed consent from parents.

You may not qualify if:

• patients that previously underwent lung POCUS by the same lung POCUS operator during the same visit to AKUH
• chest tube insertion or video-assisted thoracoscopic surgery (VATS) during the current visit to AKUH (since the equipment in situ and/or dressing might bias POCUS interpretation)
• inability to understand informed consent

Sponsors & Collaborators

• Aga Khan University: lead
• The Hospital for Sick Children: collaborator
• Grand Challenges Canada: collaborator

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Fatima Mir, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 20, 2018
• Study Start: April 12, 2018
• Primary Completion: December 30, 2019
• Study Completion: April 30, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

PA (1)