Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617156
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Comparison of Ventilator Versus Traditional Measurement Methods of Rapid Shallow Breathing Index for Predicting Extubation Success
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Different Ventilator Measurement Methods of Rapid Shallow Breathing Index With Traditional Methods For Prediction Successful Extubation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
In the Intensive Care Unit ICU approximately 25 of patients undergoing mechanical ventilation may experience difficulties during weaning from the ventilator This can lead to delayed extubation prolonged mechanical ventilation increased length of stay in the hospital or ICU and higher healthcare costs On the other hand premature extubation can result in secondary complications increasing morbidity and mortality rates in the ICU About 15 of patients who stop mechanical ventilation require reintubation within 48 hours Therefore it is crucial for intensivists to determine the appropriate timing for weaning from mechanical ventilation and successful extubation
A study by Yang and Tobin in 1991 discovered that the ratio of respiratory rate to tidal volume fVT known as the Rapid Shallow Breathing Index RSBI can serve as a predictor for successful weaning from mechanical ventilation An RSBI value of 105 is considered indicative of a higher likelihood of successful extubation while an RSBI value of 105 suggests a greater chance of weaning failure The Wright spirometer is commonly used in clinical practice to measure RSBI In practice the spirometer is connected to the artificial airway and the ventilator is disconnected for a 60-second respiratory measurement without the need for additional complex equipment
However due to advancements in medical technology ventilator parameters can also be used to calculate RSBI during Spontaneous Breathing Trials SBT Utilizing the ventilator to assess RSBI avoids interruptions in ventilation and reduces measurement risks Research has shown that ventilator-calculated RSBI is convenient for clinical use and is feasible in predicting weaning outcomes Nevertheless variations in ventilator models such as differences in base flow type of ventilator pressure compensation Positive End-Expiratory Pressure PEEP and bias flow may affect the accuracy of RSBI measurements obtained from the ventilator
This study aims to further explore whether different measurement methods affect the accuracy of RSBI However weaning profiles should be evaluated comprehensively using additional parameters beyond RSBI especially for patients requiring airway protection increased secretions or poor cough strength Factors such as cough strength and the amount of secretions should be considered A study on Chronic Obstructive Pulmonary Disease COPD patients found that early RSBI measurements did not accurately predict success in SBT thus this study will also analyze different disease diagnoses to provide reference for clinical assessment
End-expiratory lung volume EELV is the lung volume at the end of expiration representing the balance point between chest wall elastic recoil and lung collapse tendency and is a major factor in determining lung oxygenation capacity Changes in EELV are clinically significant with studies indicating that a decrease in dorsal EELV slope is a strong predictor of lung collapse Additionally changes in EELV during SBT may be related to the patients ability to successfully wean from mechanical ventilation Electrical Impedance Tomography EIT measures changes in lung impedance based on variations in tissue and air distribution providing cross-sectional images EELV can be estimated from End-expiratory Lung Impedance EELI which will be included as an analysis parameter alongside different RSBI measurement methods
Hypothesis There is no significant difference between RSBI values obtained from ventilator measurements and those obtained using traditional handheld spirometry in predicting successful extubation
Clinical Benefits Traditional handheld spirometry requires temporarily disconnecting the ventilator exposing staff to aerosolized droplets and potentially causing hypoxemia in patients dependent on oxygen support which may lead to abnormal physiological parameters and increased patient risk During the COVID-19 pandemic traditional spirometry was not suitable due to airborne infection control requirements and concerns about cross-infection between patients with reusable Wright spirometers were significant Using the ventilator to measure RSBI is a feasible alternative Currently SBT is commonly used to evaluate extubation success in critically ill patients Using the ventilator for RSBI measurements during SBT facilitates data acquisition and reduces environmental contamination between the ventilator and the patient
There is still debate over the standard value for RSBI measurements obtained from ventilators compared to traditional methods Some studies indicate similar results between traditional spirometry and ventilator-measured RSBI while others show significantly higher RSBI values with traditional spirometry This study will compare three different ventilator measurement methods with traditional standard measurements to explore differences in predicting extubation success Additionally changes in EELI will be compared across the four RSBI measurement methods
A study by Yang and Tobin in 1991 discovered that the ratio of respiratory rate to tidal volume fVT known as the Rapid Shallow Breathing Index RSBI can serve as a predictor for successful weaning from mechanical ventilation An RSBI value of 105 is considered indicative of a higher likelihood of successful extubation while an RSBI value of 105 suggests a greater chance of weaning failure The Wright spirometer is commonly used in clinical practice to measure RSBI In practice the spirometer is connected to the artificial airway and the ventilator is disconnected for a 60-second respiratory measurement without the need for additional complex equipment
However due to advancements in medical technology ventilator parameters can also be used to calculate RSBI during Spontaneous Breathing Trials SBT Utilizing the ventilator to assess RSBI avoids interruptions in ventilation and reduces measurement risks Research has shown that ventilator-calculated RSBI is convenient for clinical use and is feasible in predicting weaning outcomes Nevertheless variations in ventilator models such as differences in base flow type of ventilator pressure compensation Positive End-Expiratory Pressure PEEP and bias flow may affect the accuracy of RSBI measurements obtained from the ventilator
This study aims to further explore whether different measurement methods affect the accuracy of RSBI However weaning profiles should be evaluated comprehensively using additional parameters beyond RSBI especially for patients requiring airway protection increased secretions or poor cough strength Factors such as cough strength and the amount of secretions should be considered A study on Chronic Obstructive Pulmonary Disease COPD patients found that early RSBI measurements did not accurately predict success in SBT thus this study will also analyze different disease diagnoses to provide reference for clinical assessment
End-expiratory lung volume EELV is the lung volume at the end of expiration representing the balance point between chest wall elastic recoil and lung collapse tendency and is a major factor in determining lung oxygenation capacity Changes in EELV are clinically significant with studies indicating that a decrease in dorsal EELV slope is a strong predictor of lung collapse Additionally changes in EELV during SBT may be related to the patients ability to successfully wean from mechanical ventilation Electrical Impedance Tomography EIT measures changes in lung impedance based on variations in tissue and air distribution providing cross-sectional images EELV can be estimated from End-expiratory Lung Impedance EELI which will be included as an analysis parameter alongside different RSBI measurement methods
Hypothesis There is no significant difference between RSBI values obtained from ventilator measurements and those obtained using traditional handheld spirometry in predicting successful extubation
Clinical Benefits Traditional handheld spirometry requires temporarily disconnecting the ventilator exposing staff to aerosolized droplets and potentially causing hypoxemia in patients dependent on oxygen support which may lead to abnormal physiological parameters and increased patient risk During the COVID-19 pandemic traditional spirometry was not suitable due to airborne infection control requirements and concerns about cross-infection between patients with reusable Wright spirometers were significant Using the ventilator to measure RSBI is a feasible alternative Currently SBT is commonly used to evaluate extubation success in critically ill patients Using the ventilator for RSBI measurements during SBT facilitates data acquisition and reduces environmental contamination between the ventilator and the patient
There is still debate over the standard value for RSBI measurements obtained from ventilators compared to traditional methods Some studies indicate similar results between traditional spirometry and ventilator-measured RSBI while others show significantly higher RSBI values with traditional spirometry This study will compare three different ventilator measurement methods with traditional standard measurements to explore differences in predicting extubation success Additionally changes in EELI will be compared across the four RSBI measurement methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None