Effect of postural drainage on physiological parameters of patients with covid-19 hospitalized in critical care unit
Design
The study will be double blind and clinical trial.90 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients with medium to critical grade Covid-19 without intubation with respiratory symptoms in khansari and amiralmomenin Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Medium to critical grade Covid-19 without intubation with respiratory symptoms; need to receive oxygen more than 4 to 6 liters per minute with a simple mask with storage bag without re-breathing; apache svore less than 25; no acute asthma, and other lung diseases such as pulmonary edema, heart and lung disease
Exclusion criteria: death; transfer to the ward; intubation; unwillingness to participate in the study
Intervention groups
Intervention group: In this group, patients, in addition to routine ward care, will be placed in special posture evacuation situations and will be used to move pulmonary secretions and direct them to the central airways due to the force of gravity. Positions are performed in three shifts in the morning, evening and night for ten minutes.
Control group: In this group, patients will receive routine care in the intensive care unit, including chest physiotherapy.
Main outcome variables
Breathing rate; oxygen saturation percentage; blood carbon dioxide pressure; blood pH; blood bicarbonate; need to get oxygen; number of coughs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220618055209N1
Registration date:2022-06-23, 1401/04/02
Registration timing:prospective
Last update:2022-06-23, 1401/04/02
Update count:0
Registration date
2022-06-23, 1401/04/02
Registrant information
Name
Pegah Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3224 4693
Email address
nazari.pegah98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of postural drainage on physiological parameters of patients with covid-19 hospitalized in critical care unit
Public title
Effect of postural drainage on physiological parameters of patients with covid-19 hospitalized in critical care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Medium to critical grade Covid-19 without intubation with respiratory symptoms
Positive PCR test
Need to receive more than 4 to 6 liters of oxygen per minute with a simple mask with non-rebreathing storage bag
Apache score less than 25
18 to 75 years
Absence of acute asthma, and other lung diseases such as pulmonary edema, heart and lung disease
Exclusion criteria:
Reluctance to participate in the study
Do not perform any of the evacuation situations
Intubation during study
Transfer the patient to the ward
Death
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The analysis is done by the analyst and outcome evaluator (two-blind) and the participant. Analysts, evaluators and participants are not aware of the consequences of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.ARAKMU.REC.1400.246
Health conditions studied
1
Description of health condition studied
Patients with Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Breathing rate
Timepoint
Before and immediately after each intervention
Method of measurement
Physical examination
2
Description
Oxygen saturation percentage
Timepoint
Before and immediately after each intervention
Method of measurement
Pulse oximetry
3
Description
Blood carbon dioxide pressure
Timepoint
At the beginning and end of the study
Method of measurement
Venous blood gas sample test
4
Description
Blood pH
Timepoint
At the beginning and end of the study
Method of measurement
Venous blood gas sample test
5
Description
Blood bicarbonate
Timepoint
At the beginning and end of the study
Method of measurement
Venous blood gas sample test
6
Description
Need to get oxygen
Timepoint
Immediately after the intervention, one hour after each intervention and the day after the last intervention
Method of measurement
Physical examination
7
Description
Number of coughs
Timepoint
Up to one hour after the end of each intervention and the next day at the end of the intervention time
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients, in addition to routine ward care, will be placed in special posture evacuation situations and will be used to move pulmonary secretions and direct them to the central airways due to the force of gravity. Positions are performed in three shifts in the morning, evening and night for ten minutes. In each shift, three positions will be performed for the patients. The evening shift will take the position of the arch with a 45-degree angle in the upper body and a 20-degree angle in the waist. The night shift will receive the prone position and the right lateral and left lateral positions at a 45 degree angle to the bed. In each shift, the total positioning time will take a total of 30 minutes.
Category
Treatment - Other
2
Description
Control group: In this group, patients will receive routine care in the intensive care unit, including chest physiotherapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr seyed Yousef Shahtaheri
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3630
Email
yousef.sh00@gmail.com
2
Recruitment center
Name of recruitment center
Khansari hospital
Full name of responsible person
Dr seyed Yousef Shahtaheri
Street address
Khansari hospital, Daneshgah street
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5007
Email
yousef.sh00@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Seyed Yousef Shahtaheri
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street