Protocol summary

Study aim
Determining the effect of bud lip breathing on arterial blood oxygen saturation in people with COVID-19
Design
A clinical trial with a control group, with parallel groups, randomized, phase 2 on 70 patients, and random block method will be used.
Settings and conduct
Patients with COVID-19 referred to the Shahid Dr. Chamran hospital in Tehran city are selected by the convenience method and divided into two groups with Block randomization method. Then the results will be compared in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Being between 18 and 70 years old, the ability to do lip-bud breathing, Having Spo2 above 85%, breathing rate less than 40 times per minute, Positive PCR or lung involvement on CT scan. Exclusion criteria include: Heart rate less than 40 or more than 120 beats per minute, History of new cardiac arrhythmia or ischemia and Having hemoglobin less than 11 grams per deciliter.
Intervention groups
Intervention group: in this group, in addition to the usual treatments and care, the patients were taught face-to-face method, the lip bud breathing technique 2 times a day with an interval of 5 minutes and 10 times each time on the second, third and fourth days of hospitalization. Control group: This group receives only the usual treatments and care.
Main outcome variables
Arterial blood oxygen saturation, heart rate, duration of hospitalization, blood pressure, respiratory rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221124056590N1
Registration date: 2022-12-17, 1401/09/26
Registration timing: prospective

Last update: 2022-12-17, 1401/09/26
Update count: 0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
soheila yaghooby hamedan
Name of organization / entity
Shaheed Rajaie Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 7679 1267
Email address
syaghooby35@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pursed lip breathing on arterial blood oxygen saturation in patients with COVID-19
Public title
The effect of pursed lip breathing on arterial blood oxygen saturation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 18 and 70 years old The ability to do lip-bud breathing Having Spo2 above 85% Breathing rate less than 40 times per minute Positive PCR or lung involvement on CT scan
Exclusion criteria:
Heart rate less than 40 or more than 120 beats per minute History of new cardiac arrhythmia or ischemia Having hemoglobin less than 11 grams per deciliter
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
First, a convenient sampling method will be used. The samples will then be placed in quadruple blocks by random block randomization. Random allocation software is also used as a randomization tool. Non-transparent envelopes will be used and will be sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes will be opened in order and the assigned group of the participants will be revealed.
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
Ethics committee of Shahid Rajaei Cardiovascular Medical and Research Center
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park,Vali Asr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2022-11-05, 1401/08/14
Ethics committee reference number
IR.RHC.REC.1401.057

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Arterial blood oxygen saturation
Timepoint
Before the start of the intervention (second day of hospitalization) and on the fourth day of hospitalization
Method of measurement
Using a pulse oximeter

2

Description
Systolic and diastolic blood pressure
Timepoint
Before the start of the intervention (second day of hospitalization) and on the fourth day of hospitalization
Method of measurement
Using a sphygmomanometer

3

Description
Pulse Rate
Timepoint
Before the start of the intervention (second day of hospitalization) and on the fourth day of hospitalization
Method of measurement
Using a pulse oximeter

4

Description
Number of breaths per minute
Timepoint
Before the start of the intervention (second day of hospitalization) and on the fourth day of hospitalization
Method of measurement
By observing the number of chest movements per minute

5

Description
Length of hospitalization
Timepoint
At the time of discharge
Method of measurement
According to the number of days of hospitalization

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this group, in addition to the usual treatments and care, the patients were taught face-to-face method, the lip bud breathing technique 2 times a day with an interval of 5 minutes and 10 times each time on the second, third and fourth days of hospitalization.
Category
Rehabilitation

2

Description
Control group: Control group: This group receives only the usual treatments and care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dr. Chamran Hospital
Full name of responsible person
Soheila Yaghoobi Hamadan
Street address
NO.17 ,Shahid Dr Chamran Hospital,Shahid fakhrizadeh Street, Langari Street, Nobonyad square
City
Tehran
Province
Tehran
Postal code
1693716941
Phone
+98 21 2795 0000
Email
info@ChamranHospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Fereidoon Noohi
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Email
syaghooby35@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center
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
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Soheila yaghoobi Hamadan
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
009823923312
Email
syaghooby35@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Shima Hadipoorzadeh
Position
Assistant Professor of Cardiac Anesthesia
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 9223 3312
Email
shimahadipoorzadeh@gmaill.com

Person responsible for updating data

Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Soheila Yaghoobi Hamadan
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaie Cardiovascular Medical and Research Center, next to Mellat Park, Vali Asr St., Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 9223 3312
Email
syaghooby35@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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