Protocol summary
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Study aim
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To assess the effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19
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Design
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This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
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Settings and conduct
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This study will be performed in the Golastan Hospital in Kermanshah city on 90 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age 18 to 60 years;
Covid-19 infection;
Conscious;
Mild to moderate arterial oxygen saturation (80% to 90%);
Exclusion criteria:
Pregnancy;
Obesity;
Abdominal ulcers
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Intervention groups
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Intervention group 1:
Laying the patient in the prone position for 30 minutes
Intervention group 2:
Laying the patient in the orthopedic position for 30 minutes
Control group:
Laying the patient in the supine position for 30 minutes
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Main outcome variables
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Primary outcome:
Arterial blood oxygen, feeling comfortable, the severity of dyspnea
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N425
Registration date:
2022-05-10, 1401/02/20
Registration timing:
prospective
Last update:
2022-05-15, 1401/02/25
Update count:
1
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Registration date
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2022-05-10, 1401/02/20
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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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2022-05-22, 1401/03/01
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Expected recruitment end date
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2022-09-22, 1401/06/31
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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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Effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19: a randomized clinical trial
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Public title
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Effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 60 years;
Covid-19 infection;
Conscious;
Mild to moderate arterial oxygen saturation (80% to 90%);
Exclusion criteria:
Pregnancy;
Obesity;
Abdominal ulcers
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Age
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From 18 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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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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2022-05-07, 1401/02/17
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Ethics committee reference number
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IR.UMSHA.REC.1401.134
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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Covid-19
Primary outcomes
1
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Description
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Arterial blood oxygen
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Timepoint
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Before the intervention and 10 and 30 minutes after the intervention
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Method of measurement
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By using Mark Beurer pulse oximeter model P030 made in Germany
2
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Description
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Feeling comfortable
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Timepoint
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Before the intervention and 10 and 30 minutes after the intervention
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Method of measurement
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Using the visual analog scale (VAS)
3
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Description
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The severity of dyspnea
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Timepoint
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Before the intervention and 10 and 30 minutes after the intervention
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Method of measurement
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Using the analog visual analog scale (VAS)
Intervention groups
1
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Description
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Intervention group 1: Laying the patient in the prone position for 30 minutes
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Category
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Treatment - Other
2
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Description
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Intervention group 2: Laying the patient in the orthopedic position for 30 minutes
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Category
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Treatment - Other
3
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Description
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Control group: Laying the patient in the supine position for 30 minutes
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Category
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Treatment - Other
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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Hamedan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available