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Comparison of the Efficacy of High-Flow Nasal Oxygen Therapy and Noninvasive Ventilation in patients with COPD Exacerbation

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History
# Registration date Revision Id
2 2020-05-25, 1399/03/05 136831
1 2020-01-25, 1398/11/05 119234
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  • General information

    2018-07-23, 1397/05/01
    2019-07-23, 1398/05/01
    2018-10-23, 1397/08/01
    2019-10-23, 1398/08/01
    empty
    The recruitment start date was changed and the trial was started from July 2019.
    empty
    تاریخ شروع بیمارگیری تغییر کرد و از مردادماه 1398 بیمارگیری آغاز گردید.

  • Recruitment centers

    #1
    Name of recruitment center - English: Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
    Name of recruitment center - Persian: بیمارستان مسیح دانشوری
    Full name of responsible person - English: Atefeh Fakharian
    Full name of responsible person - Persian: عاطفه فخاریان
    Street address - English: Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
    Street address - Persian: تهران - خیابان شهید خیابان باهنر (نیاوران) - دارآباد - بیمارستان دکتر مسیح دانشوری
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 19556
    Phone: +98 21 2712 2000
    Fax:
    Email: fakharian_2005@yahoo.com
    Web page address:
    Name of recruitment center - English: Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
    Name of recruitment center - Persian: بیمارستان مسیح دانشوری
    Full name of responsible person - English: Atefeh Fakharian
    Full name of responsible person - Persian: عاطفه فخاریان
    Street address - English: Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
    Street address - Persian: تهران - خیابان شهید خیابان باهنر (نیاوران) - دارآباد - بیمارستان دکتر مسیح دانشوری
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 19556
    Phone: +98 21 2712 2000
    Fax:
    Email: fakharian_2005@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: atefeh fakharian
    Full name of responsible person - Persian: عاطفه فخاریان
    Street address - English: Masih Daneshvari Hospital, darabad, Shahid Bahonar Ave, Tehran, Iran
    Street address - Persian: تهران ، خيابان شهيد باهنر (نياوران)، دارآباد، بیمارستان مسیح دانشوری
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1956944413
    Phone: +98 21 2712 2000
    Fax: +98 21 2610 9680
    Email: fakharian_2005@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Atefeh Fakharian
    Full name of responsible person - Persian: عاطفه فخاریان
    Street address - English: Masih Daneshvari Hospital, Darabad, Shahid Bahonar Ave, Tehran, Iran
    Street address - Persian: تهران ، خيابان شهيد باهنر (نياوران)، دارآباد، بیمارستان مسیح دانشوری
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1956944413
    Phone: +98 21 2712 2000
    Fax: +98 21 2610 9680
    Email: fakharian_2005@yahoo.com
    Web page address:

Protocol summary

Study aim
The efficacy of treatment of exacerbated chronic pulmonary patients with the treatment of high flow of oxygen therapy compared with receiving non-invasive ventilation
Design
Clinical trial, randomized, two parallel intervention groups, double-blind. Sample size 68
Settings and conduct
Patients' recovery with two methods of high-flow Nasal Oxygen Therapy and Noninvasive Ventilation by examining ABG parameters will be compared and analyzed (effectiveness of these two methods). Randomization will be done according to computer generated random numbers. The studied population is part of the target population (all people with exacerbated COPD) who come to Dr. Masih Daneshvari hospital.
Participants/Inclusion and exclusion criteria
The presence of chronic obstructive pulmonary disease (COPD) and acute respiratory failure; 7.25 < pH < 7.35; Arterial pressure of carbon dioxide (PaCO2) equal to or greater than 45 mmHg.
Intervention groups
People with exacerbated chronic pulmonary disease are divided into two groups. In one group, the effectiveness of NIV and in the other group the effectiveness of HFNT are examined and compared.
Main outcome variables
ABG

General information

Reason for update
The recruitment start date was changed and the trial was started from July 2019.
Acronym
IRCT registration information
IRCT registration number: IRCT20160516027929N7
Registration date: 2020-01-25, 1398/11/05
Registration timing: retrospective

Last update: 2020-05-31, 1399/03/11
Update count: 1
Registration date
2020-01-25, 1398/11/05
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of High-Flow Nasal Oxygen Therapy and Noninvasive Ventilation in patients with COPD Exacerbation
Public title
Comparison of the Efficacy of High-Flow Nasal Oxygen Therapy and Noninvasive Ventilation in patients with COPD Exacerbation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of chronic obstructive pulmonary disease (COPD) and acute respiratory failure pH < 7.35 Arterial pressure of carbon dioxide (PaCO2) equal to or greater than 45mmHg
Exclusion criteria:
- Mechanical ventilation in the past 60 days (using any non-invasive ventilation or high blood oxygen through the nasal cannula (HFNT) prior to enrollment in the study and after the onset of acute upper respiratory failure (AHRF) - Non-invasive ventilation for home care - Undesirable clinical condition (require a vasopressor for> 24 hours, acute coronary syndrome or life-threatening arrhythmias ( - Refusal of treatment - Disorder in more than two organs -Heart failure - The respiratory tract requires a tracheal intubation - Trauma or burn in the neck and face - Pregnancy - Refusal of consent - enter to other research protocols
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple Unit of randomization : individual Tools used in randomization : table of random numbers Included patients, in a simple randomized evaluation using even and odd numbers, would got codes for each treatment group. In case of odd numbers, the patient would be enrolled in the group one to receive high flow oxygenation at the first stage and following a washout period, take noninvasive ventilation. On the other hand, patients gotten even numbers would receive noninvasive ventilation for the first stage. Then, after a washout period, high oxygen therapy would be prescribed.
Blinding (investigator's opinion)
Double blinded
Blinding description
To treat any possible complications, the care provider is not blind. Other blind groups are as below: Participants, investigators, outcome assessor, Data analyse.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti of Medical Sciences
Street address
Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
City
Tehran
Province
Tehran
Postal code
19556
Approval date
2019-06-01, 1398/03/11
Ethics committee reference number
IR.SBMU.NRITLD.REC.1398.032

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease (COPD)
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with (acute) exacerbation

Primary outcomes

1

Description
PaCO2
Timepoint
before intervention- one hour after - half hour after- after intervention
Method of measurement
ABG

Secondary outcomes

1

Description
SaO2
Timepoint
befor intervention-one hour after-half hour after- after intervention
Method of measurement
ABG

Intervention groups

1

Description
Intervention group: Intervention group: First, ABG will be measured and then HFNT will be performed and after 1 hour, ABG will be measured again. Then 30 minutes will be passed without the device, after which ABG will be measured again. Eventually 1 hour NIV will be performed and ABG will be measured with the VPAP device.
Category
Treatment - Devices

2

Description
Intervention group 2: First ABG will be measured and then the NIV will be performed, after 1 hour, ABG will be measured by the VPAP. Next 30 minutes will be without device and then ABG will be measured again. Then 1 hour HFNT will be done and ABG will be evaluated at the end.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
Full name of responsible person
Atefeh Fakharian
Street address
Masih Daneshvari Hospital, Darabad, Bahonar Ave, Tehran Town, Iran
City
Tehran
Province
Tehran
Postal code
19556
Phone
+98 21 2712 2000
Email
fakharian_2005@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Street address
Masih Daneshvari Hospital, Darabad, Shahid Bahonar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2000
Fax
+98 21 2610 9680
Email
fakharian_2005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Poulmonologist
Street address
Masih Daneshvari Hospital, Darabad, Shahid Bahonar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2000
Email
fakharian_2005@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Poulmonology
Street address
Masih Daneshvari Hospital, Darabad, Shahid Bahonar Ave, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2000
Email
fakharian_2005@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonologist
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 912 155 1615
Fax
Email
fakharian_2005@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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