Comparison of Ventilator Versus Traditional Measurement Methods of Rapid Shallow Breathing Index for Predicting Extubation Success

NCT06617156 | Not Yet Recruiting

• 1 other identifier: 202407034RIND
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Rapid Shallow Breathing Index (RSBI) (respiratory rate f / tidal volume VT) is a crucial indicator for predicting whether a patient can successfully wean off mechanical ventilation. This study aims to explore the clinical value of measuring RSBI using different methods in predicting successful extubation. Study Methods: A prospective study was conducted in the medical and surgical intensive care units of a teaching hospital. Data were collected from patients who required intubation and mechanical ventilation due to respiratory failure from August 2024 to July 2026. The RSBI measured under different ventilator settings was compared with the traditional standard hand-held Wright spirometer measurement. The ventilator measurement methods were divided into three categories: PSV 5 cmH2O with PEEP 5 cmH2O, CPAP 5 cmH2O, and CPAP 0 cmH2O. The study analyzed the differences in RSBI measurements obtained by these methods and their ability to predict successful extubation, as well as other related factors, including the influence of different ventilator models, ventilation modes, and parameter settings on RSBI values. RSBI can vary across different patient populations and measurement methods. This study aims to validate the RSBI displayed by ventilators against the traditional standard measurement, providing a reliable predictive capability for successful extubation. Furthermore, it seeks to facilitate clinical application and assist healthcare providers in determining the appropriate timing for extubation, reducing unnecessary prolonged use or premature removal of mechanical ventilation, and thereby lowering the incidence of complications and healthcare costs.

Conditions

Respiratory Failure

Keywords

Ventilator weaning; Spirometry; Rapid shallow breathing index; Ventilator; Wright spirometer

Outcome Measures

Primary Outcomes (1)

• RSBI Measured by the Ventilator

  Accuracy of Predicting Extubation Success Using RSBI Measured by the Ventilator

  60 minutes

Secondary Outcomes (4)

• bias flow settings within different ventilators influence RSBI measurements.

  60 minutes

• Comparison of RSBI Values with and without PEEP in COPD Patients

  60 minutes

• End-Expiratory Lung Impedance (EELI) Measured

  60 minutes

• Different Ventilator Inspiratory Pressures (PS) and Expiratory Pressures (PEEP)

  60 minutes

Study Arms (1)

Group 1

RSBI Value Acquisition: All patients will undergo four methods to obtain the RSBI value Measurement Procedure: (1) The method of priority for measurement will be determined by random sampling (by drawing from an opaque envelope). (2) After each measurement, settings will return to baseline, and the next measurement can only occur after 10 minutes. (3) Collecting Ventilation Data: After changing the ventilation mode, wait 2 minutes to ensure stable breathing, then divide MV by RR to obtain tidal volume, and use RR divided by VT to obtain the RSBI value. (4)Simultaneous Measurement of EELI Changes Using Four Methods with EIT

Other: RSBI Value Evaluation

Interventions

RSBI Value Evaluation OTHER

Spirometer Measurement: The traditional method for calculating RSBI involves the use of a spirometer (Wright MK20; Ferraris Medical Ltd., Hertford, England), equipped with a disposable bacterial filter at the front end, connected to the artificial airway to measure the minute ventilation of the patient's spontaneous breathing over one minute. Three Measurement Methods from the Ventilator: A. PSV at 5 cmH2O with PEEP at 5 cmH2O B. CPAP at 5 cmH2O C. CPAP at 0 cmH2O. Electrical impedance tomography (EIT) will be secured around the patient's thorax using a silicone belt, positioned at the fifth or sixth intercostal space, with 16 evenly spaced electrodes. Measurement data will be obtained by passing a small electrical current around the chest, utilizing the principle of resistance.

Group 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU patients for whom the attending physician anticipates initiation of a Spontaneous Breathing Trial (SBT) and plans for extubation.

You may qualify if:

• Age 18 years or older.
• Admission to the Intensive Care Unit (ICU).
• Endotracheal intubation with mechanical ventilation for more than 24 hours.
• P/F ratio \> 150; FiO2 ≤ 40% and Positive End-Expiratory Pressure (PEEP) ≤ 8 cmH2O.
• Hemodynamically stable, without the need for vasoactive drugs or requiring only low doses.

You may not qualify if:

• Significant cardiac ischemia or arrhythmia.
• Patients with a tracheostomy.
• Patients with an endotracheal tube with an internal diameter smaller than 7.0 mm.
• Patients who have undergone repeated intubations within the past month.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (20)

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  PMID: 21958982 RESULT

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  PMID: 15942342 RESULT

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  PMID: 17962636 RESULT

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  PMID: 28270888 RESULT

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  PMID: 32166566 RESULT

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  PMID: 10806150 RESULT

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• Rittayamai N, Ratchaneewong N, Tanomsina P, Kongla W. Validation of rapid shallow breathing index displayed by the ventilator compared to the standard technique in patients with readiness for weaning. BMC Pulm Med. 2021 Oct 2;21(1):310. doi: 10.1186/s12890-021-01680-7.

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• Schmidt GA, Girard TD, Kress JP, Morris PE, Ouellette DR, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, L Hough C, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Truwit JD; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. Official Executive Summary of an American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Am J Respir Crit Care Med. 2017 Jan 1;195(1):115-119. doi: 10.1164/rccm.201610-2076ST.

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  PMID: 34465570 RESULT

Related Links

• Sermkaew T, Kongpolprom N. Electrical impedance tomography monitoring for predicting lung collapse after positive end expiratory pressure decrement in recovering acute respiratory distress syndrome. European Respiratory Journal. 2021;58.

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Yu Luen Huang

CONTACT

+886223123456; yu3385@ntuh.gov.tw

Yung Hsuan Chen, MD

CONTACT

+886972652700; cyh3258@ntuh.gov.tw

Study Design

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

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: October 16, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 15, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09