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Rapid Shallow Breathing Index Survey: A Predictor of Non-Invasive Ventilation Necessity in Patients with Chronic Obstructive Pulmonary Disease Exacerbation: A prospective descriptive study

Protocol summary

Summary
In a prospective descriptive study, ninety eight patients over 40 years old with documented COPD exacerbation who were referred to emergency department of Imam Reza hospital, Tabriz, Iran were studied. In the present study, we aimed at evaluating the use of Rapid Shallow Breathing Index (a ratio determined by the frequency (f) divided by the tidal volume (VT).) In NIV requirement in COPD patients. Also, ABG parameters and APACHE II scoring were measured in each patient. The inclusion criteria were: All the patients over 40 years old, COPD Exacerbation, History of smoking at least twenty pack/year. The exclusion criteria: Respiratory arrest, cardiovascular instability, lack of patient cooperation, upper airway obstruction, possibility of increased aspiration risk, morbid obesity, increase in secretions, recent facial trauma or gastroesophageal surgery, impaired mask fixation, nasopharyngeal abnormalities, craniofacial trauma, lack of patient consent. To determine the need for NIV, in all patients, ABG and simultaneous RSBI were measured using ventilator model “Vector ST40” with BLPAP mode EPAP=5 cm H2O, IPAP=10 cm H2O. Furthermore, medical treatments (intravenous corticosteroid, salbutamol spray, atrovent spray, antibiotics, and oxygen therapy) were administered. Furthermore, medical treatments (intravenous corticosteroid, salbutamol spray, atrovent spray, antibiotics, and oxygen therapy) were administered. Duration and method of oxygen therapy was as following for all patients: Indications for commencement of non-invasive ventilation (NIV) included exacerbation of COPD with PH<7.35 and PaCO2>45mmHg or PaO2<60mmHg (SpO2<90%) despite receiving Max FIO2 of 60%. Titrated Oxygen therapy was initiated using Venturi mask at FIO2 of 24% to 60% for all patients based on pulse oximetry every 20 minutes to achieve SpO2>90% (for maximum of two hours). In case of not achieving SPO2>90% despite receiving FIO2>60%, patients underwent NIV. After administering the above-mentioned treatments and oxygen therapy for two hours, required variables on admission, one hour and two hours after admission were measured; ultimately patients were divided into two groups of requiring non-invasive ventilation (group I) and not requiring non-invasive ventilation (group II). Patients requiring non-invasive ventilation were hospitalized after consulting with a pulmonologist and patients who were not hospitalized or did not require non-invasive ventilation, depending on clinical condition.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201304282496N10
Registration date: 2013-04-29, 1392/02/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-29, 1392/02/09
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences, Iran
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2011-08-30, 1390/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rapid Shallow Breathing Index Survey: A Predictor of Non-Invasive Ventilation Necessity in Patients with Chronic Obstructive Pulmonary Disease Exacerbation: A prospective descriptive study
Public title
Rapid Shallow Breathing Index Survey: A Predictor of Non-Invasive Ventilation Necessity in Patients with Chronic Obstructive Pulmonary Disease Exacerbation: A prospective descriptive study
Purpose
Diagnostic
Inclusion/Exclusion criteria
The inclusion criteria: all the patients over 40 years old; COPD exacerbation; history of smoking at least twenty pack/year. Exclusion criteria: respiratory arrest; rdiovascular instability; lack of patient cooperation; upper airway obstruction; possibility of increased aspiration risk; morbid obesity; increase in secretions; recent facial trauma or gastroesophageal surgery; impaired mask fixation; nasopharyngeal abnormalities; craniofacial trauma; lack of patient consent.
Age
From 40 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research-Vice chancellor, Tabriz University of Medical Sciences, Iran
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Approval date
2010-01-09, 1388/10/19
Ethics committee reference number
883

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease Exacerbation
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified

Primary outcomes

1

Description
Rapid Shallow Breathing Index
Timepoint
On admission, one hour and two hours after admission
Method of measurement
A ratio determined by the frequency (f) during one minute divided by tidal volume (VT)

Secondary outcomes

1

Description
Acute Physiology And Chronic Health Evaluation II
Timepoint
On admission, one hour and two hours after admission
Method of measurement
Temperature; heart rate; hematocrit; white blood cell count; respiratory rate; PaO2/F1O2; creatinine, PH, Na, K, GCS Score and blood pressure

Intervention groups

1

Description
All patient's RSBI were measured using ventilator model “Vector ST40” with BLPAP mode EPAP=5 cm H2O, IPAP=10 cm H2O.
Category
Diagnosis

2

Description
Arterial blood gas (ABG) sampling from patients
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Shakouri, M. D.
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hassan Soleimanpour
Position
Anesthesiologist/ Associate professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hassan Soleimanpour
Position
Anesthesiologist/ Associate professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hassan Soleimanpour
Position
Anesthesiologist/ Associate professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
h_mofid1357@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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