Evaluation of the effect of using high flow oxygen delivery through nasal cannula (HFNC) with different currents, in improving the respiratory symptoms of patients with chronic obstructive pulmonary disease (COPD) referred to Masih Daneshvari Hospital
Evaluation of oxygen therapy through HFNC with different currents, in improving the respiratory symptoms of patients with COPD in Masih Daneshvari Hospital.
Design
The present study is a clinical trial with three intervention groups, with parallel and one-way blind groups, randomized and with a sample size of 30 patients.
Settings and conduct
This study is performed as a clinical trial in patients with COPD referred to Masih Daneshvari Hospital in Tehran who need to be hospitalized and receive respiratory support. The collected data are real and experimental. Based on the objectives and hypotheses of this study, the clinical conditions and parameters obtained from the analysis of blood gases and spirometry of patients after receiving high-current conductive oxygen through the nasal cannula will be examined. Randomization is done using codes assigned to each patient and based on the file number. For the treatment of any possible complication, the main therapist has knowledge of the groups. Other groups kept blind include the researcher analyzing the data.
Participants/Inclusion and exclusion criteria
Signing a written consent form, no intubation, hypoxemic respiratory distress
Intervention groups
Patients are divided into 3 groups according to the opinion of the therapist with different flows of 30, 40, and 60 liters per minute. The air will be transferred to the patient through the nasal cannula and the patient will be taught how to breathe properly before starting oxygen therapy. Except for FiO2, the other settings of the high flow device are set equally for all three groups, and the air temperature is set at 34 ° C to ensure proper humidity to the patient's inhaled air.
Main outcome variables
Arterial blood gas analysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160516027929N9
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
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
2021-03-21, 1400/01/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using high flow oxygen delivery through nasal cannula (HFNC) with different currents, in improving the respiratory symptoms of patients with chronic obstructive pulmonary disease (COPD) referred to Masih Daneshvari Hospital
Public title
Evaluation of the effect of HFNC use in COPD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing a written consent form
No intubation
Hypoxemic respiratory distress
Exclusion criteria:
PaCO2> 65
pH < 7.28
Age less than 18 years
Cardiovascular disorders that prevent respiratory rehabilitation
Diagnosis of medical staff based on the patient's absence from participating in this study
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization. Randomization unit: individual. Randomization tool: Random number table. Patients are divided into 3 groups treated with different flows of 30, 40, and 60 liters per minute based on the codes assigned to each patient (using file number).
Blinding (investigator's opinion)
Single blinded
Blinding description
To prevent any possible complications, the primary caregiver is aware of the allocation of treatment groups. Patients in the study were also not blinded to the treatment they were receiving. Researchers responsible for data collection and analysis are not aware of the allocation of different study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.220
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
chronic obstructive pulmonary disease
Primary outcomes
1
Description
Forced expiratory volume in first second
Timepoint
Before starting oxygen therapy, 24 hours later
Method of measurement
Spirometry
2
Description
Oxygen saturation
Timepoint
Before starting oxygen therapy, 24 hours later
Method of measurement
Pulse oximetry
3
Description
Forced vital capacity
Timepoint
Before starting oxygen therapy, 24 hours later
Method of measurement
Spirometry
4
Description
Partial pressure of carbon dioxide
Timepoint
Before starting oxygen therapy, 24 hours later
Method of measurement
VBG analysis
Secondary outcomes
1
Description
Borg scale
Timepoint
Before starting oxygen therapy, 24 hours later
Method of measurement
Questionnaire review
2
Description
CAT score
Timepoint
Before starting oxygen therapy, 24 hours later
Method of measurement
Questionnaire review
Intervention groups
1
Description
First intervention group: In this group, patients receive oxygen therapy through a high-flow device. The patient's transport oxygen flow is set to 30. The inlet air temperature is set to 34 ° C to ensure proper humidity to the patient's inhaled air.
Category
Treatment - Devices
2
Description
Second intervention group: In this group, patients receive oxygen therapy through a high-flow device. The patient's transport oxygen flow is set to 40. The inlet air temperature is set to 34 ° C to ensure proper humidity to the patient's inhaled air.
Category
Treatment - Devices
3
Description
Third intervention group: In this group, patients receive oxygen therapy through a high-flow device. The patient's transport oxygen flow is set to 60. The inlet air temperature is set to 34 ° C to ensure proper humidity to the patient's inhaled air.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Mahrokh Fargah
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
mahrokhfargah61@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198396411
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413c
Phone
+98 21 2610 5050
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
Reyhaneh Zahiri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biotechnology
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
zahirireyhane@gmail.com
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
There is 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
Undecided - It is not yet known if there will be a plan to make this available