Acute Respiratory FailureRSBINCT04780503
The Value of Rapid Shallow Breathing Indeks in Predicting Non-invasive Mechanical
An observational study of Acute Respiratory Failure, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
There are some criteria such as the most frequently used parameters to predict the failure of non-invasive mechanical ventilation, the APACHE 2 score, the presence of pneumonia and ARDS in the etiology, and no improvement in one hour of treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Rapid Shallow Breathing Index
- How many people
- 267 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2020to 9 Jan 2021
- 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: The study population consisted of only patients (patients admitted to the emergency department with acute respiratory failure)
Who may be able to join
- This study included patients 18 years of age and older with acute respiratory failure of any etiology and in need of NIVM. NIMV Initiation Criteria;
- Presentation of acute respiratory acidosis (pH ⩽7.35)
- Tachypnea (respiratory rate >20-24 breaths/minute) despite the standart medical teraphy
- Arterial oxygen tension/inspiratory oxygen fraction ratio (PaO2/FIO2) ⩽200
Who cannot join
- Pregnancy, trauma, NIMV intolerance and IMV initiation criteria;
- Cardiac or respiratory arrest
- Unstable cardiac arrhythmias
- Hemodynamic instability
- Severe encephalopathy (GCS <10)
- Severe upper gastrointestinal bleeding
Show all 9Show fewer
- Facial trauma
- Upper airway obstruction
- Inability to protect the airway
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
IKCU, Ataturk Training and Research Hospital, Department of Emergency Medicine
Izmir, 35360
About this study
Official title: The Rapid Shallow Breathing Index as an Early Predictor for Intubation and Mortality in Patients Undergoing Non-invasive Mechanical Ventilation in Acute Respiratory Failure
There are some criteria such as the most frequently used parameters to predict the failure of non-invasive mechanical ventilation, the APACHE 2 score, the presence of pneumonia and ARDS in the etiology, and no improvement in one hour of treatment. However, APECHE 2 score, which is the broadest of these criteria and includes others, is a complex scoring in which a large number of parameters are evaluated together, dependent on laboratory results and still leaves the final decision to the physician with a complete evaluation. In addition, the APACHE 2 score is a more commonly used method for intensive care patients rather than emergency patients who need a quick decision. Therefore, there is a need for a fast and practical method that can predict NIMV failure and determine early intubation decision in the management of patients admitted to the emergency department with acute dyspnea. Rapid Shallow Breathing Index (RSBI) is a parameter calculated by dividing the respiratory rate by the tidal volume and is used to predict whether patients who are intubated in intensive care unit can be extubated successfully.
The aim of this study is to evaluate the success of RSBI in predicting intubation and mortality in patients presented to the emergency department with acute respiratory failure and had NIMV indication.
Read the detailed description
Respiratory failure is a challenging health problem that constitutes a significant part of emergency room visits (1). Acute respiratory failure treatment is a complex process in which pharmacological and non-pharmacological methods are used in combination. Non-invasive Mechanical Ventilation (NIMV) and Invasive Mechanical Ventilation (IMV) are life-saving methods commonly used in the emergency department in severe respiratory failure (2). In patients with severe dyspnea, NIMV improves alveolar gas exchange, with very successful results in selected patients (3). However, while NIMV cannot be used in patients who are unconscious, unable to protect the airway, have upper gastrointestinal bleeding and facial trauma and cannot adapt to non-invasive mechanical ventilation, these patients have IMV indication. Both methods are quite successful when used in selected cases. Therefore, patient selection is very important for NIMV and IMV (4). It is known that endotracheal intubation increases the risk of developing complications such as ventilator-associated pneumonia and sepsis. Therefore, unnecessary endotracheal intubation and invasive mechanical ventilation therapy are expected to increase mortality (5). On the other hand, delayed intubation decision is known to be an independent risk factor for increased mortality when NIMV fails (6) (7) (8). A method that predicts NIMV failure and enables effective mortality estimation may be useful in facilitating patient selection and providing appropriate treatment to patients. There are some criteria predicting that NIMV will fail in patients with severe respiratory distress and may be guiding for early intubation. The most commonly used of these are high APACHE 2 score, ARDS or pneumonia as the etiology of respiratory distress, advanced age, and no clinical improvement after 1 hour of treatment (9). However, APECHE 2 score, which is the broadest of these criteria and includes others, is a complex scoring in which a large number of parameters are evaluated together, dependent on laboratory results and still leaves the final decision to the physician with a complete evaluation. In addition, the APACHE 2 score is a more commonly used method for intensive care patients rather than emergency patients who need a quick decision. Therefore, there is a need for a fast and practical method that can predict NIMV failure and determine early intubation decision in the management of patients admitted to the emergency department with acute dyspnea. Rapid Shallow Breathing Index (RSBI) is a parameter calculated by dividing the respiratory rate by the tidal volume and is used to predict whether patients who are intubated in intensive care unit can be extubated successfully (10). In a study by Berg et al. (11) evaluating the endotracheal intubation and mortality rates of patients who underwent NIMV, it was found that the RSBI value above 105 obtained with a single measurement was significant in predicting NIV failure. Although this result is significant, it is not sufficient to make an early intubation decision. Considering that serial measurements are found to be more meaningful than a single measurement while predicting weaning success (12), serial measurements can provide more successful results in predicting intubation and mortality of patients receiving NIMV. Although the RSBI value obtained immediately after the initiation of NIMV is high, it is possible for the patient to be relieved after the patient has been treated with NIMV for a while and thus, the RSBI value may also decrease. For this reason, after these patients have been treated for a while, obtaining RSBI value once again and looking at the patient's response to treatment may provide more meaningful results.
The aim of this study is to evaluate the success of RSBI in predicting intubation and mortality in patients presented to the emergency department with acute respiratory failure and had NIMV indication.
- Conditions
- Acute Respiratory Failure
- Being tested
- Rapid Shallow Breathing Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Shallow Breathing IndexDiagnostic test
The RSBI is defined as the ratio of respiratory frequency to tidal volume.
| Study group | Role | What they receive |
|---|---|---|
| Intubation Group/ Non-Intubation Group | Intubation group: Patients who failed noninvasive mechanical ventilation and who underwent endotracheal intubation Non-Intubation Group: Patients whose noninvasive mechanical ventilation is successful and endotracheal intubation is not applied Receives: Diagnostic Test: Rapid Shallow Breathing Index | |
| Dying patients / Surviving patients | Dying patients :Patients with in-hospital mortality presenting with acute respiratory failure Surviving patients: Patients presenting and surviving due to acute respiratory failure Receives: Diagnostic Test: Rapid Shallow Breathing Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Shallow Breathing Index (RSBI)
The RSBI is the ratio of respiratory frequency to tidal volume (f/VT). RSBI values measured at admission and 30 minutes are the primary outcome measures of the study.
Measured: 0-30 minute.
Secondary outcomes (4)
Mean arterial pressure
It is obtained by summing twice the diastolic pressure with the systolic pressure and dividing the obtained value by 3.
Measured: 0-30 minute
Respiratory rate
It refers to the patient's respiratory rate in 1 minute.
Measured: 0-30 minute
Heart rate
It refers to the patient's Heart rate in 1 minute.
Measured: 0-30 minute
Oxygen saturation
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood.
Measured: 0-30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start9 Jan 2020
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Yamanoğlu, Izmir Katip Celebi University
- Investigators
- Fatih Topal, MD, Study chair, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780503
- Sponsor's protocol ID
- 2020-GOKAE-0011
- Acronym
- RSBI
- Status last verified
- Sep 2023
- First submitted
- 1 Mar 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have a plan to make individual participant data (IPD) available to other researchers.
Publications
Chatila W, Jacob B, Guaglionone D, Manthous CA. The unassisted respiratory rate-tidal volume ratio accurately predicts weaning outcome. Am J Med. 1996 Jul;101(1):61-7. doi: 10.1016/s0002-9343(96)00064-2.
PubMed 8686717Shrestha AP, Shrestha R, Shrestha SK, Pradhan A. Prevalence of Dyspnea among Patients Attending the Emergency Department of a Tertiary Care Hospital: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2019 Sep-Oct;57(219):302-306. doi: 10.31729/jnma.4582.
PubMed 32329452Huang CC, Muo CH, Wu TF, Chi TY, Shen TC, Hsia TC, Shih CM. The application of non-invasive and invasive mechanical ventilation in the first episode of acute respiratory failure. Intern Emerg Med. 2021 Jan;16(1):83-91. doi: 10.1007/s11739-020-02315-1. Epub 2020 Mar 30.
PubMed 32232782Mas A, Masip J. Noninvasive ventilation in acute respiratory failure. Int J Chron Obstruct Pulmon Dis. 2014 Aug 11;9:837-52. doi: 10.2147/COPD.S42664. eCollection 2014.
PubMed 25143721Hayzy RC, McSpasson JI. Noninvasive ventilation in adults with acute respiratory failure: Benefits and contraindications. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, 2020.
Girou E, Schortgen F, Delclaux C, Brun-Buisson C, Blot F, Lefort Y, Lemaire F, Brochard L. Association of noninvasive ventilation with nosocomial infections and survival in critically ill patients. JAMA. 2000 Nov 8;284(18):2361-7. doi: 10.1001/jama.284.18.2361.
PubMed 11066187Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
PubMed 15190137Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
PubMed 28860265Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.
PubMed 26464393Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, Pelaia P, Principi T, Gregoretti C, Beltrame F, Pennisi MA, Arcangeli A, Proietti R, Passariello M, Meduri GU. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001 Nov;27(11):1718-28. doi: 10.1007/s00134-001-1114-4. Epub 2001 Oct 16.
PubMed 11810114Karthika M, Al Enezi FA, Pillai LV, Arabi YM. Rapid shallow breathing index. Ann Thorac Med. 2016 Jul-Sep;11(3):167-76. doi: 10.4103/1817-1737.176876.
PubMed 27512505Berg KM, Lang GR, Salciccioli JD, Bak E, Cocchi MN, Gautam S, Donnino MW. The rapid shallow breathing index as a predictor of failure of noninvasive ventilation for patients with acute respiratory failure. Respir Care. 2012 Oct;57(10):1548-54. doi: 10.4187/respcare.01597. Epub 2012 Mar 12.
PubMed 22417884
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rapid Shallow Breathing Index as an Early Predictor for Intubation and Mortality in Patients Undergoing Non-invasive Mechanical Ventilation in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04780503
- Acronym / sponsor ID
- RSBI / 2020-GOKAE-0011
- Conditions
- Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 3 Mar 2021 (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.
There are some criteria such as the most frequently used parameters to predict the failure of non-invasive mechanical ventilation, the APACHE 2 score, the presence of pneumonia and ARDS in the etiology, and no improvement in one hour of treatment. However, APECHE 2 score, which is the broadest of these criteria and includes others, is a complex scoring in which a large number of parameters are evaluated together, dependent on laboratory results and still leaves the final decision to the physician with a complete evaluation. In addition, the APACHE 2 score is a more commonly used method for intensive care patients rather than emergency patients who need a quick decision. Therefore, there is a need for a fast and practical method that can predict NIMV failure and determine early intubation decision in the management of patients admitted to the emergency department with acute dyspnea. Rapid Shallow Breathing Index (RSBI) is a parameter calculated by dividing the respiratory rate by the tidal volume and is used to predict whether patients who are intubated in intensive care unit can be extubated successfully.
The aim of this study is to evaluate the success of RSBI in predicting intubation and mortality in patients presented to the emergency department with acute respiratory failure and had NIMV indication.
Detailed description
Respiratory failure is a challenging health problem that constitutes a significant part of emergency room visits (1). Acute respiratory failure treatment is a complex process in which pharmacological and non-pharmacological methods are used in combination. Non-invasive Mechanical Ventilation (NIMV) and Invasive Mechanical Ventilation (IMV) are life-saving methods commonly used in the emergency department in severe respiratory failure (2). In patients with severe dyspnea, NIMV improves alveolar gas exchange, with very successful results in selected patients (3). However, while NIMV cannot be used in patients who are unconscious, unable to protect the airway, have upper gastrointestinal bleeding and facial trauma and cannot adapt to non-invasive mechanical ventilation, these patients have IMV indication. Both methods are quite successful when used in selected cases. Therefore, patient selection is very important for NIMV and IMV (4). It is known that endotracheal intubation increases the risk of developing complications such as ventilator-associated pneumonia and sepsis. Therefore, unnecessary endotracheal intubation and invasive mechanical ventilation therapy are expected to increase mortality (5). On the other hand, delayed intubation decision is known to be an independent risk factor for increased mortality when NIMV fails (6) (7) (8). A method that predicts NIMV failure and enables effective mortality estimation may be useful in facilitating patient selection and providing appropriate treatment to patients. There are some criteria predicting that NIMV will fail in patients with severe respiratory distress and may be guiding for early intubation. The most commonly used of these are high APACHE 2 score, ARDS or pneumonia as the etiology of respiratory distress, advanced age, and no clinical improvement after 1 hour of treatment (9). However, APECHE 2 score, which is the broadest of these criteria and includes others, is a complex scoring in which a large number of parameters are evaluated together, dependent on laboratory results and still leaves the final decision to the physician with a complete evaluation. In addition, the APACHE 2 score is a more commonly used method for intensive care patients rather than emergency patients who need a quick decision. Therefore, there is a need for a fast and practical method that can predict NIMV failure and determine early intubation decision in the management of patients admitted to the emergency department with acute dyspnea. Rapid Shallow Breathing Index (RSBI) is a parameter calculated by dividing the respiratory rate by the tidal volume and is used to predict whether patients who are intubated in intensive care unit can be extubated successfully (10). In a study by Berg et al. (11) evaluating the endotracheal intubation and mortality rates of patients who underwent NIMV, it was found that the RSBI value above 105 obtained with a single measurement was significant in predicting NIV failure. Although this result is significant, it is not sufficient to make an early intubation decision. Considering that serial measurements are found to be more meaningful than a single measurement while predicting weaning success (12), serial measurements can provide more successful results in predicting intubation and mortality of patients receiving NIMV. Although the RSBI value obtained immediately after the initiation of NIMV is high, it is possible for the patient to be relieved after the patient has been treated with NIMV for a while and thus, the RSBI value may also decrease. For this reason, after these patients have been treated for a while, obtaining RSBI value once again and looking at the patient's response to treatment may provide more meaningful results.
The aim of this study is to evaluate the success of RSBI in predicting intubation and mortality in patients presented to the emergency department with acute respiratory failure and had NIMV indication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation Group/ Non-Intubation Group | – | Diagnostic Test: Rapid Shallow Breathing IndexIntubation group: Patients who failed noninvasive mechanical ventilation and who underwent endotracheal intubation Non-Intubation Group: Patients whose noninvasive mechanical ventilation is successful and endotracheal intubation is not applied |
| Dying patients / Surviving patients | – | Diagnostic Test: Rapid Shallow Breathing IndexDying patients :Patients with in-hospital mortality presenting with acute respiratory failure Surviving patients: Patients presenting and surviving due to acute respiratory failure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of only patients (patients admitted to the emergency department with acute respiratory failure)
Key inclusion criteria (4 listed)
- This study included patients 18 years of age and older with acute respiratory failure of any etiology and in need of NIVM. NIMV Initiation Criteria;
- Presentation of acute respiratory acidosis (pH ⩽7.35)
- Tachypnea (respiratory rate >20-24 breaths/minute) despite the standart medical teraphy
- Arterial oxygen tension/inspiratory oxygen fraction ratio (PaO2/FIO2) ⩽200
Key exclusion criteria (9 listed)
- Pregnancy, trauma, NIMV intolerance and IMV initiation criteria;
- Cardiac or respiratory arrest
- Unstable cardiac arrhythmias
- Hemodynamic instability
- Severe encephalopathy (GCS <10)
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 |
|---|---|---|
| Rapid Shallow Breathing IndexThe RSBI is defined as the ratio of respiratory frequency to tidal volume. | Diagnostic test | Dying patients / Surviving patients, Intubation Group/ Non-Intubation Group |
Primary outcome
Rapid Shallow Breathing Index (RSBI)
Time frame: 0-30 minute.
The RSBI is the ratio of respiratory frequency to tidal volume (f/VT). RSBI values measured at admission and 30 minutes are the primary outcome measures of the study.
4 secondary outcomes
Mean arterial pressure
Time frame: 0-30 minute
Respiratory rate
Time frame: 0-30 minute
Heart rate
Time frame: 0-30 minute
Oxygen saturation
Time frame: 0-30 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 8686717Chatila W, Jacob B, Guaglionone D, Manthous CA. The unassisted respiratory rate-tidal volume ratio accurately predicts weaning outcome. Am J Med. 1996 Jul;101(1):61-7. doi: 10.1016/s0002-9343(96)00064-2.
- Results publication: PubMed 32329452Shrestha AP, Shrestha R, Shrestha SK, Pradhan A. Prevalence of Dyspnea among Patients Attending the Emergency Department of a Tertiary Care Hospital: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2019 Sep-Oct;57(219):302-306. doi: 10.31729/jnma.4582.
- Results publication: PubMed 32232782Huang CC, Muo CH, Wu TF, Chi TY, Shen TC, Hsia TC, Shih CM. The application of non-invasive and invasive mechanical ventilation in the first episode of acute respiratory failure. Intern Emerg Med. 2021 Jan;16(1):83-91. doi: 10.1007/s11739-020-02315-1. Epub 2020 Mar 30.
- Results publication: PubMed 25143721Mas A, Masip J. Noninvasive ventilation in acute respiratory failure. Int J Chron Obstruct Pulmon Dis. 2014 Aug 11;9:837-52. doi: 10.2147/COPD.S42664. eCollection 2014.
- Results publicationHayzy RC, McSpasson JI. Noninvasive ventilation in adults with acute respiratory failure: Benefits and contraindications. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, 2020.
- Results publication: PubMed 11066187Girou E, Schortgen F, Delclaux C, Brun-Buisson C, Blot F, Lefort Y, Lemaire F, Brochard L. Association of noninvasive ventilation with nosocomial infections and survival in critically ill patients. JAMA. 2000 Nov 8;284(18):2361-7. doi: 10.1001/jama.284.18.2361.
- Results publication: PubMed 15190137Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
- Results publication: PubMed 28860265Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
- Results publication: PubMed 26464393Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.
- Results publication: PubMed 11810114Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, Pelaia P, Principi T, Gregoretti C, Beltrame F, Pennisi MA, Arcangeli A, Proietti R, Passariello M, Meduri GU. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001 Nov;27(11):1718-28. doi: 10.1007/s00134-001-1114-4. Epub 2001 Oct 16.
- Results publication: PubMed 27512505Karthika M, Al Enezi FA, Pillai LV, Arabi YM. Rapid shallow breathing index. Ann Thorac Med. 2016 Jul-Sep;11(3):167-76. doi: 10.4103/1817-1737.176876.
- Results publication: PubMed 22417884Berg KM, Lang GR, Salciccioli JD, Bak E, Cocchi MN, Gautam S, Donnino MW. The rapid shallow breathing index as a predictor of failure of noninvasive ventilation for patients with acute respiratory failure. Respir Care. 2012 Oct;57(10):1548-54. doi: 10.4187/respcare.01597. Epub 2012 Mar 12.
- Individual participant dataSharing planned: No. We have a plan to make individual participant data (IPD) available to other researchers.
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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.
Fatih Topal, MD study chair
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Shallow Breathing Index (RSBI) (time frame: 0-30 minute.). 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 NCT04780503, which also lists 12 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 22 Sep 2023.