Protocol summary
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Study aim
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The efficacy of treatment of exacerbated chronic pulmonary patients with the treatment of high flow of oxygen therapy compared with receiving non-invasive ventilation
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Design
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Clinical trial, randomized, two parallel intervention groups, double-blind. Sample size 68
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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ABG
General information
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Reason for update
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The recruitment start date was changed and the trial was started from July 2019.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-01-25, 1398/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-23, 1398/05/01
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Expected recruitment end date
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2019-10-23, 1398/08/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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To treat any possible complications, the care provider is not blind. Other blind groups are as below: Participants, investigators, outcome assessor, Data analyse.
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-01, 1398/03/11
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Ethics committee reference number
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IR.SBMU.NRITLD.REC.1398.032
Health conditions studied
1
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Description of health condition studied
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Chronic obstructive pulmonary disease (COPD)
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ICD-10 code
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J44.1
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ICD-10 code description
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Chronic obstructive pulmonary disease with (acute) exacerbation
Primary outcomes
1
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Description
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PaCO2
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Timepoint
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before intervention- one hour after - half hour after- after intervention
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Method of measurement
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ABG
Secondary outcomes
1
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Description
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SaO2
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Timepoint
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befor intervention-one hour after-half hour after- after intervention
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Method of measurement
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ABG
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available