Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study

NCT06313372 | Not Yet Recruiting

• 1 other identifier: CA2085
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD). The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:

• Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.
• What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD. This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus. In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study. Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Keywords

Respiratory oscillometry; Impulse oscillometry; Forced oscillation technique

Outcome Measures

Primary Outcomes (2)

• Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale.

  Participants are asked to rank in order of clinical importance the different respiratory oscillometry parameters (R5, R20, X5, AX, R5-R20, delta X5) from 1 to 6 Consensus is achieved when ≥ 70% of the participants give the same ranking order within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their ranking again.

  When consensus is achieved within an individual Delphi round or through to study end, up to 1 year

• Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)

  Cut-off values used to define abnormality are proposed for each parameter (R5, X5, AX, and R5-R20) and the participants/experts are asked for their level of agreement with the proposed cut-off value being assessed. An example of the type of statement used for this component of the survey is as follows: For R5, a result with a z-score \> 1.64 is considered abnormal. A. Agree Strongly B. Agree Moderately C. Agree Slightly D. Disagree Slightly E. Disagree Moderately F. Disagree Strongly Consensus is achieved when ≥ 70% of the participants give the same level of agreement for each statement within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their level of agreement again.

  When consensus is achieved within an individual Delphi round or through to study end, up to 1 year

Secondary Outcomes (2)

• Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)

  When consensus is achieved within an individual Delphi round or through to study end, up to 1 year

• Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)

  When consensus is achieved within an individual Delphi round or through to study end, up to 1 year

Interventions

Respiratory oscillometry DIAGNOSTIC_TEST

This a Delphi study where we are obtaining expert opinion and input on the use of respiratory oscillometry (a diagnostic respiratory test) in the assessment and management of patients with asthma or chronic obstructive pulmonary disease. The participants are respiratory specialists/pulmonologists. They are sharing their insights into the clinical use of respiratory oscillometry via a series of online surveys. The Delphi process is used in an attempt to achieve consensus as to how respiratory oscillometry is used in clinical practice. As such there is no intervention being used on the study participants, but they are sharing insights on how the respiratory test is used in their clinical practice in order to obtain consensus on this use.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the Delphi study will be respiratory specialists with expertise in the application of respiratory oscillometry in clinical practice and who routinely use respiratory oscillometry in clinical practice. Clinical use is defined as respiratory specialists who order and/or interpret respiratory oscillometry in day-to-day clinical practice.

You may qualify if:

• Respiratory specialist in active clinical practice ≥ 12 months.
• Use respiratory oscillometry ≥ 2 tests per week

You may not qualify if:

• Only use respiratory oscillometry when participating in clinical trials
• Employee or stockholder of pharmaceutical company
• Employee or stockholder of oscillometry manufacturer
• Employee or stockholder of tobacco/vaping companies.

Sponsors & Collaborators

• Scius Healthcare Solutions Pty Ltd: lead
• Chiesi Australia: collaborator

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Ping Chung, MBBS

  Fiona Stanley Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George M Krassas, B Pharm

CONTACT

+61400950086; george@scius.com.au

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share