The Value of Rapid Shallow Breathing Indeks in Predicting Non-invasive Mechanical

NCT04780503 | Completed

• 1 other identifier: 2020-GOKAE-0011
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  0-30 minute.

Secondary Outcomes (4)

• Mean arterial pressure

  0-30 minute

• Respiratory rate

  0-30 minute

• Heart rate

  0-30 minute

• Oxygen saturation

  0-30 minute

Study Arms (2)

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

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

Diagnostic Test: Rapid Shallow Breathing Index

Interventions

Rapid Shallow Breathing Index DIAGNOSTIC_TEST

The RSBI is defined as the ratio of respiratory frequency to tidal volume.

Dying patients / Surviving patients; Intubation Group/ Non-Intubation Group

Eligibility Criteria

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

Study Population

The study population consisted of only patients (patients admitted to the emergency department with acute respiratory failure)

You may qualify if:

• 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

You may not qualify if:

• 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
• Facial trauma
• Upper airway obstruction
• Inability to protect the airway

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

IKCU, Ataturk Training and Research Hospital, Department of Emergency Medicine

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 8686717 BACKGROUND

• Shrestha 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.

  PMID: 32329452 RESULT

• Huang 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.

  PMID: 32232782 RESULT

• Mas 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.

  PMID: 25143721 RESULT

• Hayzy RC, McSpasson JI. Noninvasive ventilation in adults with acute respiratory failure: Benefits and contraindications. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, 2020.

  RESULT

• 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.

  PMID: 11066187 RESULT

• Esteban 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.

  PMID: 15190137 RESULT

• Rochwerg 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.

  PMID: 28860265 RESULT

• Demoule 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.

  PMID: 26464393 RESULT

• Antonelli 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.

  PMID: 11810114 RESULT

• Karthika 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.

  PMID: 27512505 RESULT

• Berg 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.

  PMID: 22417884 RESULT

Study Officials

• Fatih Topal, MD

  Izmir Katip Celebi University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Specialist

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: January 9, 2020
• Primary Completion: January 9, 2021
• Study Completion: January 9, 2021
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)