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

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ClinicalTrials.gov Identifier: NCT04780503
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Adnan Yamanoğlu, Izmir Katip Celebi University

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.


Condition or disease Intervention/treatment
Acute Respiratory Failure Diagnostic Test: Rapid Shallow Breathing Index

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.

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Study Type : Observational
Actual Enrollment : 267 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 9, 2020
Actual Primary Completion Date : January 9, 2021
Actual Study Completion Date : January 9, 2021


Group/Cohort Intervention/treatment
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
The RSBI is defined as the ratio of respiratory frequency to tidal volume.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: 0-30 minute ]
    It is obtained by summing twice the diastolic pressure with the systolic pressure and dividing the obtained value by 3.

  2. Respiratory rate [ Time Frame: 0-30 minute ]
    It refers to the patient's respiratory rate in 1 minute.

  3. Heart rate [ Time Frame: 0-30 minute ]
    It refers to the patient's Heart rate in 1 minute.

  4. Oxygen saturation [ Time Frame: 0-30 minute ]
    Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consisted of only patients (patients admitted to the emergency department with acute respiratory failure)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780503


Locations
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Turkey
IKCU, Ataturk Training and Research Hospital, Department of Emergency Medicine
İzmir, Turkey, 35360
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
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Study Chair: Fatih Topal, MD Izmir Katip Celebi University
Publications of Results:
Hayzy RC, McSpasson JI. Noninvasive ventilation in adults with acute respiratory failure: Benefits and contraindications. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, 2020.

Other Publications:
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Responsible Party: Adnan Yamanoğlu, Emergency Medicine Specialist, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT04780503    
Other Study ID Numbers: 2020-GOKAE-0011
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have a plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases