Respiratory FailureNCT06617156
Comparison of Ventilator Versus Traditional Measurement Methods of Rapid Shallow Breathing Index for Predicting Extubation Success
An observational study of Respiratory Failure, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- RSBI Value Evaluation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2024to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients for whom the attending physician anticipates initiation of a Spontaneous Breathing Trial (SBT) and plans for extubation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Different Ventilator Measurement Methods of Rapid Shallow Breathing Index With Traditional Methods For Prediction Successful Extubation
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.
Read the 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 (f/VT), 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 patient's 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.
- Conditions
- Respiratory Failure
- Being tested
- RSBI Value Evaluation
- Keywords
- Ventilator weaning, Spirometry, Rapid shallow breathing index, Ventilator, Wright spirometer
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSBI Value EvaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: RSBI Value Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSBI Measured by the Ventilator
Accuracy of Predicting Extubation Success Using RSBI Measured by the Ventilator
Measured: 60 minutes
Secondary outcomes (4)
bias flow settings within different ventilators influence RSBI measurements.
Comparison of the Impact of Different Ventilator Bias Flows on RSBI Values: Analyze how variations in bias flow settings within different ventilators influence RSBI measurements.
Measured: 60 minutes
Comparison of RSBI Values with and without PEEP in COPD Patients
Comparison of RSBI Values with and without PEEP in COPD Patients: Assess differences in RSBI values for Chronic Obstructive Pulmonary Disease (COPD) patients with and without the application of PEEP.
Measured: 60 minutes
End-Expiratory Lung Impedance (EELI) Measured
Comparison of End-Expiratory Lung Impedance (EELI) Measured by Electrical Impedance Tomography (EIT) Across Four Measurement Methods: Use EIT to compare EELI measurements obtained from four different RSBI measurement methods.
Measured: 60 minutes
Different Ventilator Inspiratory Pressures (PS) and Expiratory Pressures (PEEP)
Comparison of RSBI Values and Predictive Capability Based on Different Ventilator Inspiratory Pressures (PS) and Expiratory Pressures (PEEP): Evaluate how variations in inspiratory pressure (PS) and expiratory pressure (PEEP) affect RSBI values and their predictive accuracy for extubation success.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start16 Oct 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617156
- Sponsor's protocol ID
- 202407034RIND
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ramirez-Torres CA, Rivera-Sanz F, Sufrate-Sorzano T, Pedraz-Marcos A, Santolalla-Arnedo I. Closed Endotracheal Suction Systems for COVID-19: Rapid Review. Interact J Med Res. 2023 Jan 10;12:e42549. doi: 10.2196/42549.
PubMed 36548950Kheir F, Myers L, Desai NR, Simeone F. The effect of flow trigger on rapid shallow breathing index measured through the ventilator. J Intensive Care Med. 2015 Feb;30(2):103-6. doi: 10.1177/0885066613504538. Epub 2013 Sep 24.
PubMed 24067546Souza LC, Lugon JR. The rapid shallow breathing index as a predictor of successful mechanical ventilation weaning: clinical utility when calculated from ventilator data. J Bras Pneumol. 2015 Nov-Dec;41(6):530-5. doi: 10.1590/S1806-37132015000000077.
PubMed 26785962Patel KN, Ganatra KD, Bates JH, Young MP. Variation in the rapid shallow breathing index associated with common measurement techniques and conditions. Respir Care. 2009 Nov;54(11):1462-6.
PubMed 19863829Desai NR, Myers L, Simeone F. Comparison of 3 different methods used to measure the rapid shallow breathing index. J Crit Care. 2012 Aug;27(4):418.e1-6. doi: 10.1016/j.jcrc.2011.07.070. Epub 2011 Sep 29.
PubMed 21958982Duarte H, Fran A DLG, Portes MCF, Faria APAJ, Fontes RM, Wittmer VNLO, Barbalho-Moulim MC, Paro FVM. Comparison of different methods of obtaining the rapid shallow breathing index. Braz J Anesthesiol. 2023 Sep-Oct;73(5):578-583. doi: 10.1016/j.bjane.2021.05.001. Epub 2021 May 15.
PubMed 34004236Dasta JF, McLaughlin TP, Mody SH, Piech CT. Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1266-71. doi: 10.1097/01.ccm.0000164543.14619.00.
PubMed 15942342Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
PubMed 17962636Goncalves EC, Lago AF, Silva EC, de Almeida MB, Basile-Filho A, Gastaldi AC. How Mechanical Ventilation Measurement, Cutoff and Duration Affect Rapid Shallow Breathing Index Accuracy: A Randomized Trial. J Clin Med Res. 2017 Apr;9(4):289-296. doi: 10.14740/jocmr2856w. Epub 2017 Feb 21.
PubMed 28270888Vetrugno L, Guadagnin GM, Brussa A, Orso D, Garofalo E, Bruni A, Longhini F, Bove T. Mechanical ventilation weaning issues can be counted on the fingers of just one hand: part 1. Ultrasound J. 2020 Mar 13;12(1):9. doi: 10.1186/s13089-020-00161-y.
PubMed 32166566Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
PubMed 10806150McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.
PubMed 23215559Yang KL, Tobin MJ. A prospective study of indexes predicting the outcome of trials of weaning from mechanical ventilation. N Engl J Med. 1991 May 23;324(21):1445-50. doi: 10.1056/NEJM199105233242101.
PubMed 2023603Meade M, Guyatt G, Cook D, Griffith L, Sinuff T, Kergl C, Mancebo J, Esteban A, Epstein S. Predicting success in weaning from mechanical ventilation. Chest. 2001 Dec;120(6 Suppl):400S-24S. doi: 10.1378/chest.120.6_suppl.400s.
PubMed 11742961Rittayamai 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.
PubMed 34600522
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Ventilator Measurement Methods of Rapid Shallow Breathing Index With Traditional Methods For Prediction Successful Extubation
- ClinicalTrials.gov ID
- NCT06617156
- Acronym / sponsor ID
- 202407034RIND
- Conditions
- Respiratory Failure
- Keywords
- Ventilator weaning, Spirometry, Rapid shallow breathing index, Ventilator, Wright spirometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (f/VT), 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 patient's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: RSBI Value EvaluationRSBI 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients for whom the attending physician anticipates initiation of a Spontaneous Breathing Trial (SBT) and plans for extubation.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSBI Value EvaluationSpirometer 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. | Other | Group 1 |
Primary outcome
RSBI Measured by the Ventilator
Time frame: 60 minutes
Accuracy of Predicting Extubation Success Using RSBI Measured by the Ventilator
4 secondary outcomes
bias flow settings within different ventilators influence RSBI measurements.
Time frame: 60 minutes
Comparison of RSBI Values with and without PEEP in COPD Patients
Time frame: 60 minutes
End-Expiratory Lung Impedance (EELI) Measured
Time frame: 60 minutes
Different Ventilator Inspiratory Pressures (PS) and Expiratory Pressures (PEEP)
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Results publication: PubMed 36548950Ramirez-Torres CA, Rivera-Sanz F, Sufrate-Sorzano T, Pedraz-Marcos A, Santolalla-Arnedo I. Closed Endotracheal Suction Systems for COVID-19: Rapid Review. Interact J Med Res. 2023 Jan 10;12:e42549. doi: 10.2196/42549.
- Results publication: PubMed 24067546Kheir F, Myers L, Desai NR, Simeone F. The effect of flow trigger on rapid shallow breathing index measured through the ventilator. J Intensive Care Med. 2015 Feb;30(2):103-6. doi: 10.1177/0885066613504538. Epub 2013 Sep 24.
- Results publication: PubMed 26785962Souza LC, Lugon JR. The rapid shallow breathing index as a predictor of successful mechanical ventilation weaning: clinical utility when calculated from ventilator data. J Bras Pneumol. 2015 Nov-Dec;41(6):530-5. doi: 10.1590/S1806-37132015000000077.
- Results publication: PubMed 19863829Patel KN, Ganatra KD, Bates JH, Young MP. Variation in the rapid shallow breathing index associated with common measurement techniques and conditions. Respir Care. 2009 Nov;54(11):1462-6.
- Results publication: PubMed 21958982Desai NR, Myers L, Simeone F. Comparison of 3 different methods used to measure the rapid shallow breathing index. J Crit Care. 2012 Aug;27(4):418.e1-6. doi: 10.1016/j.jcrc.2011.07.070. Epub 2011 Sep 29.
- Results publication: PubMed 34004236Duarte H, Fran A DLG, Portes MCF, Faria APAJ, Fontes RM, Wittmer VNLO, Barbalho-Moulim MC, Paro FVM. Comparison of different methods of obtaining the rapid shallow breathing index. Braz J Anesthesiol. 2023 Sep-Oct;73(5):578-583. doi: 10.1016/j.bjane.2021.05.001. Epub 2021 May 15.
- Results publication: PubMed 15942342Dasta JF, McLaughlin TP, Mody SH, Piech CT. Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1266-71. doi: 10.1097/01.ccm.0000164543.14619.00.
- Results publication: PubMed 17962636Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
- Results publication: PubMed 28270888Goncalves EC, Lago AF, Silva EC, de Almeida MB, Basile-Filho A, Gastaldi AC. How Mechanical Ventilation Measurement, Cutoff and Duration Affect Rapid Shallow Breathing Index Accuracy: A Randomized Trial. J Clin Med Res. 2017 Apr;9(4):289-296. doi: 10.14740/jocmr2856w. Epub 2017 Feb 21.
- Results publication: PubMed 32166566Vetrugno L, Guadagnin GM, Brussa A, Orso D, Garofalo E, Bruni A, Longhini F, Bove T. Mechanical ventilation weaning issues can be counted on the fingers of just one hand: part 1. Ultrasound J. 2020 Mar 13;12(1):9. doi: 10.1186/s13089-020-00161-y.
- Results publication: PubMed 10806150Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
- Results publication: PubMed 23215559McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.
- Individual participant dataSharing planned: Undecided
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Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Luen Huang (+886223123456 ext. 263945, yu3385@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSBI Measured by the Ventilator (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617156, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.