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Study Protocol

Comparative observational study on diagnostic utility of impulse oscillometry vs spirometry in obstructive airway diseases

[version 1; peer review: 2 not approved]
PUBLISHED 14 Jun 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Obstructive airway diseases, including chronic obstructive pulmonary disease (COPD) and asthma, pose significant global health challenges. Early and accurate diagnosis is crucial for effective management. Although Spirometry has traditionally been the cornerstone of diagnostics, Impulse Oscillometry (IOS) has emerged as a promising alternative. This study aims to compare the diagnostic performance of Spirometry and IOS in patients attending the Respiratory Medicine Department at the Acharya Vinoba Bhave Rural Hospital, Sawangi, India.

Methods

A Comparative Observational Study was conducted between August 2022 and August 2024, enrolling patients who met specific inclusion criteria. Data were collected through a comprehensive medical history, clinical examination, routine blood tests, chest radiography, High-resolution computed tomography (HRCT), spirometry, and IOS. Key parameters, including Forced expiratory volume in the first second FEV1, FEV1/FVC (Forced Expiratory Volume), (Forced Expiratory Volume) FVC, (Forced Expiratory Flow) FEF 25-75 for Spirometry, and R5, R20, fres, X5, and AX for IOS, were analyzed using the Chi-Square Test and Student’s t-test with SPSS 27.0 and GraphPad Prism 7.0.

Expected outcome

The study included 130 participants with the primary objective of evaluating IOS’s diagnostic advantages of IOS over spirometry. Our findings demonstrate that IOS offers enhanced sensitivity for diagnosing early small airway diseases, which is a crucial factor for early diagnosis in both pediatric and adult populations.

Keywords

Impulse Oscillometry, Spirometry, Obstructive Airway Diseases, COPD Diagnosis, Respiratory Medicine, Diagnostic Sensitivity

Introduction

Asthma and Chronic Obstructive Pulmonary Disease (COPD) are prominent constituents of obstructive airway diseases and are ranked as the fourth leading cause of death globally. In the context of obstructive airway diseases (OADs), pulmonary function measurement serves as a pivotal factor in diagnosing these conditions, gauging disease severity, predicting prognosis, and evaluating therapeutic response.1

Patients exhibiting symptoms of dyspnea, cough, chronic expectoration, and exposure to harmful chemicals warrant suspicion of COPD. The diagnostic confirmation of COPD is achieved through spirometry, particularly when the FEV1/FVC ratio is less than 70% after bronchodilator administration. Notably, as the disease progressed, FEV1 demonstrated a decline.2

In the case of asthma, patients may present with recurrent chest wheezing, cough, chest tightness, or breathing difficulties, often accompanied by other allergic symptoms. The diagnosis of asthma, according to (Global Initiative for Asthma) guidelines, involves identifying airway reversibility after bronchodilator administration, specifically, a greater than 200 ml or 12% increase in FEV1 in spirometry. Asthma, a growing health concern, is diagnosed based on clinical history, physical examination, and pulmonary function testing following the GINA guidelines.3

Spirometry is the gold standard diagnostic test for OADs and is routinely performed as a pulmonary function test (PFT). However, it requires active patient participation and physical dexterity, which may be challenging for young children, the elderly, and individuals with physical or cognitive impairment. Additionally, the forced expiratory maneuver in spirometry can trigger volume-dependent closure of the small airways.4 Impulse Oscillometry (IOS) was developed as a modernized approach to traditional pulmonary function testing. It employs pressure flow oscillations at the mouth, superimposing over the patient’s tidal breaths at various oscillation frequencies to assess the respiratory system’s resistance and reactance.5

The IOS represents a variant of the forced oscillation technique (FOT), which investigates the mechanical properties of the respiratory system, including resistance and elasticity, across a frequency range of 5–20 Hz. Unlike FOT, which employs sinusoidal waves, IOS assesses the respiratory machine’s response to a triangular strain pulse.6 The key advantage of FOT/IOS lies in its use of simpler tidal breathing, requiring less cooperation and effort compared to spirometry. Furthermore, because IOS is conducted without forceful respiratory movements, it is less likely to affect airway smooth muscle tone.7

Several parameters were measured through IOS, including R5, representing the resistance at 5 Hz frequency, which reflects total airway resistance; R20, indicating resistance at a 20 Hz frequency, representing larger airway resistance; X5, denoting reactance at 5 Hz frequency, which reflects the elasticity of peripheral airways; and Ax, signifying the Area of Reactance, reflecting the degree of peripheral airway obstruction.8

Reversible blockage and bronchial hyperresponsiveness are key criteria for asthma diagnosis. The IOS exhibited sensitivity and accuracy in both aspects. A 30-35 percent decrease in R5 is considered a significant bronchodilator response. Asthmatic individuals typically present higher R5, fres, and AX values, whereas X5 values are lower. This pattern was also observed during bronchoprovocation testing, with an increase in R5, fres, and AX and a decrease in X5. Notably, a 20% reduction in FEV1 corresponds to a 50% decrease in X5, which is a more sensitive metric for detecting bronchial hyperreactivity.9

Gong et al. demonstrated that reactance parameters correlate more strongly with lung function than resistance parameters in COPD patients. They propose that changes in X5 over time could serve as an effective disease monitoring tool.5 For COPD diagnosis, even when spirometric values are within the normal range, patients with COPD-related complaints exhibit increased pulmonary resistance and decreased pulmonary reactance. Hence, IOS is highly sensitive in detecting subtle changes in pulmonary function, making it a more sensitive modality for this purpose.10

Aim

To study the utility of Impulse oscillometry vs Spirometry in obstructive airway diseases.

Objective

  • 1. To study the utility of Impulse oscillometry over Spirometry in OADs

  • 2. To compare diagnostic parameters of IOS vs Spirometry

  • 3. To study the parameters of OADs in the pediatric and adult age groups of patients

Study setting

The study will be conducted at Acharya Vinoba Bhave Rural Hospital (AVBRH), located in Sawangi, Wardha, in the central part of India. AVBRH is a tertiary care hospital affiliated with Jawaharlal Nehru Medical College and serves as the primary site for this research. The study will be conducted over a two-year period, from August 2022 to August 2024.

Study design

This study was designed as a Comparative Observational Study, which means that no interventions or treatments will be administered to study participants. Data were collected through observation and diagnostic tests.

Study population

The study population will consist of patients attending the outpatient department (OPD) or admitted to the inpatient department (IPD) of the Respiratory Medicine Department at AVBRH, Sawangi, and Wardha. The inclusion and exclusion criteria for patient selection were as follows:

Inclusion criteria

  • Clinically suspected cases of obstructive airway diseases.

  • Age above 6 years.

  • Patients capable of understanding and performing the investigations required.

Exclusion criteria

  • Patients who are positive for tuberculosis.

  • History of recent abdominal, thoracic, eye, or ear surgery.

  • Patients with oral abnormalities.

  • Individuals who were suspected of having COVID-19 or tested positive for COVID-19 by RT-PCR.

  • Patients unwilling to provide informed consent.

Methods

Informed consent

Before data collection began, all patients who met the inclusion criteria were approached, informed about the study, and provided with a detailed explanation of the study’s purpose, procedures, potential risks, and benefits. Written informed consent will be obtained from the patients who voluntarily agree to participate. Consent will be obtained from legal guardians of participants under the age of 18 years.

Medical history

A comprehensive medical history of each participant was obtained. This will include information on the patient’s past medical conditions, family history of respiratory diseases, exposure to risk factors (e.g., smoking and occupational exposure), and previous treatments for respiratory conditions.

Clinical examination

A complete clinical examination will be performed by qualified healthcare professionals. This examination will include the assessment of vital signs, general appearance, respiratory rate, lung sounds, and any physical signs or symptoms related to obstructive airway diseases.

Routine blood examinations

A set of routine blood tests, as specified in the annex, will be conducted to assess various hematological and biochemical parameters that may be relevant to the diagnosis of obstructive airway diseases.

Radiological investigations

  • 1. Chest X-ray: Standard posterior-anterior (PA) and lateral chest X-rays will be used to assess lung structure and identify any abnormalities.

  • 2. High-resolution computed tomography (HRCT) of the thorax: HRCT scans will be performed when needed to provide more detailed images of the lung anatomy and pathology.

Pulmonary function tests

  • 1. Spirometry Spirometry will be performed to measure key lung function parameters, including Forced Expiratory Volume in 1 s (FEV1), FEV1/FVC ratio, Forced Vital Capacity (FVC), and Forced Expiratory Flow (FEF) between 25% and 75% of FVC (FEF 25-75).

  • 2. Impulse Oscillometry (IOS): Impulse Oscillometry will be conducted to assess airway resistance and reactance. The parameters to be measured include R5 the Total Airway Resistance), R20 (Large Airway Resistance), Resonant Frequency (Fres), X5 (Reactance at 5 Hz), and area under reactance curve (AX).

Data recording and management

  • 1. Data collected during these examinations and tests will be meticulously recorded to ensure accuracy and completeness.

  • 2. Electronic data capture tools or standardized forms may be used for data entry.

  • 3. Patient information will be anonymized and coded to maintain confidentiality and privacy.

Quality control

  • 1. To ensure the quality and reliability of the data, all diagnostic tests were performed by trained and certified healthcare professionals.

  • 2. Calibration and maintenance of equipment (spirometers and IOS devices) will be performed regularly to ensure accurate measurements.

  • 3. Interobserver and intraobserver variability will be monitored and minimized.

Sample size calculation

The sample size for this study was calculated using Daniel’s formula, with a 95% confidence interval. The calculated sample size was 65 patients in each group, totaling 130 participants.

Statistical analysis

The collected data will be analyzed using statistical methods, including the Chi-Square Test for categorical variables and the student’s t-test for continuous variables. The analysis will be performed with the assistance of statistical software,

Ethical considerations

The Institutional Ethics Committee of the Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol on 18th July 2022. Prior to commencing the study, written informed consent was obtained from all participants, providing them with a comprehensive explanation of the study’s objectives. We prioritized interviewees’ privacy and comfort during the interview process. Reference Number: DMIHER (DU)/IEC/2022/74.

Expected outcomes/results

The study aims to enroll 130 participants and expects to demonstrate the advantages of Impulse Oscillometry over conventional spirometry in diagnosing obstructive airway diseases. It also seeks to identify the parameters that are sensitive to COPD and asthma. The primary hypothesis is that the IOS will show better sensitivity as a diagnostic tool for early small airway diseases in both children and adults.

Dissemination

After completion of the study, we will publish it in an indexed journal or conference.

Study status

The study has not yet started after the publication of the protocol, we will start recruitment in the study.

Discussion

In this study, we performed a comprehensive comparison of Impulse Oscillometry (IOS) and spirometry as diagnostic tools for the early detection of asthma and Chronic Obstructive Pulmonary Disease (COPD). In individuals with asthma and COPD, we expected to find elevated values of respiratory resistance indices R5 and R20, while reactance index X5 should exhibit a marked reduction.

A study conducted by Al-Mutairi et al.11 in 2007 reported that the IOS demonstrated a sensitivity of 31.3% in diagnosing asthma, surpassing traditional pulmonary function tests, which had a sensitivity of 19.6%. Similarly, their research revealed that IOS had a sensitivity of 38.95% for diagnosing COPD compared to 47.4% sensitivity for conventional pulmonary function tests. Furthermore, the IOS exhibited a sensitivity of 45.8%, which was notably higher than that of pulmonary function tests (28.8%) for identifying individuals without any respiratory illnesses.11

Importantly, reactance values have been used to gauge the progression of COPD. IOS resistance measurements have shown potential for identifying early stage COPD and subtle alterations in the small airways, particularly in response to bronchodilators and bronchogenic challenges.12

Building on the findings of prior research,13 our study anticipated a higher sensitivity of reactance measurements in asthmatic patients and a heightened sensitivity of resistance measurements in individuals with COPD. Our study aimed to highlight the exceptional sensitivity of IOS in detecting obstructive pulmonary diseases. We examined the comparative utility of Spirometry and IOS measures, including R5, R20, and X5, in patients with asthma and COPD. Our findings have the potential to elucidate the correlation between R5 stage and COPD severity. Prior research has also indicated strong associations between R5, X5, and FEV1.14

It is noteworthy that patients with advanced COPD tend to exhibit greater within-breath variations in Xrs5, as indicated by Kanda et al.15 Furthermore, recent studies suggest that the ability to differentiate between COPD and asthma patients using inspiratory-expiratory X5 analysis is more effective than relying solely on total respiratory IOS.16 In the context of IOS, it is worth highlighting that inspiratory assessments tend to offer superior accuracy compared to expiratory assessments.17 These insights contribute to a better understanding of the diagnostic potential of IOS and the nuanced nuances of its measurements in different respiratory conditions.

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Sarkar S and Jadhav U. Comparative observational study on diagnostic utility of impulse oscillometry vs spirometry in obstructive airway diseases [version 1; peer review: 2 not approved]. F1000Research 2024, 13:635 (https://doi.org/10.12688/f1000research.143898.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 14 Jun 2024
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Reviewer Report 24 Sep 2024
Alberto Vidal Grell, Clínica MEDS, Santiago, Chile 
Not Approved
VIEWS 4
Dear editor:

Introduction is very long, it can be limited.
The population to be studied is very heterogeneous, a pediatric patient with asthma of an adult patient with COPD is not the same. A child with ... Continue reading
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CITE
HOW TO CITE THIS REPORT
Grell AV. Reviewer Report For: Comparative observational study on diagnostic utility of impulse oscillometry vs spirometry in obstructive airway diseases [version 1; peer review: 2 not approved]. F1000Research 2024, 13:635 (https://doi.org/10.5256/f1000research.157620.r323777)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
8
Cite
Reviewer Report 18 Sep 2024
Warawut Chaiwong, Chiang Mai University, Chiang Mai, Chiang Mai, Thailand 
Not Approved
VIEWS 8
I read an interesting a study protocol by Sarkar et al. The authors aim to compare the diagnostic performance of spirometry and IOS in patients with obstructive airway diseases including asthma and COPD. However, this study protocol has some major ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Chaiwong W. Reviewer Report For: Comparative observational study on diagnostic utility of impulse oscillometry vs spirometry in obstructive airway diseases [version 1; peer review: 2 not approved]. F1000Research 2024, 13:635 (https://doi.org/10.5256/f1000research.157620.r323770)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 14 Jun 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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