Protocol summary

Summary
The purpose of this study is to the comparison of the effect of position change on the arterial oxygen saturation in different parts of the body in patients with and without cardiac and respiratory disorders. Inclusion criteria are lack of nail varnish and glue on the location of the probes and the ability to position change. Exclusion criteria are request to withdraw from the study at any stage and low consciousness level. In this clinical trial 165 patients will be selected by using non randomized technique. At first, the oxygen saturation in different positions and in different parts of the body will be measured by pulse oximetry and will be recorded in the check list. Then the patient will be placed in semi-sitting position for 15 minutes and arterial blood oxygen saturation will be measured at the same time in the three organs earlobes, fingertips and the tip of toe. Then the the patient will be placed in the supine, prone and semi-sitting position and oxygen saturation will be measured in different organs at the same time. Also oxygen saturation in the three groups of patients normal, respiratory and cardiac patients will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082817800N2
Registration date: 2016-09-11, 1395/06/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-11, 1395/06/21
Registrant information
Name
Samane Najafi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 5027
Email address
najafi.s@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of position change on the arterial oxygen saturation in different parts of the body in patients with and without cardiac and respiratory disorders
Public title
The comparison of the effect of position change on the arterial oxygen saturation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lack of nail varnish and glue on the location of the probes; the ability to position change. Exclusion criteria: request to withdraw from the study at any stage; low consciousness level.
Age
From 16 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 165
Randomization (investigator's opinion)
N/A
Randomization description
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Approval date
2014-05-21, 1393/02/31
Ethics committee reference number
GMU.REC.1393.19

Health conditions studied

1

Description of health condition studied
Respiratory patients
ICD-10 code
J44.8, J45
ICD-10 code description
Other specified chronic obstructive pulmonary disease; Asthma, unspecified

2

Description of health condition studied
Cardiac patients
ICD-10 code
I20.9, I21
ICD-10 code description
Angina pectoris, unspecified; Acute myocardial infarction, unspecified

Primary outcomes

1

Description
Arterial blood oxygen saturation
Timepoint
15 minutes
Method of measurement
Pulse oximetry device is a standard device to measure arterial blood oxygen saturation that for its reliability will be used equivalent reliability. For this purpose, its accuracy will be checked with another pulse oximetry device before the working every day.

Secondary outcomes

empty

Intervention groups

1

Description
At first, The patients without cardiac and respiratory disease will be placed in semi-sitting position for 15 minutes and arterial blood oxygen saturation will be measured at the same time in the three organs earlobes, fingertips and the tip of toe. Then the the patient will be placed in the supine, prone and semi-sitting position and oxygen saturation will be measured in different organs at the same time.
Category
Treatment - Other

2

Description
At first, In patient with cardiac and respiratory disease will be placed in semi-sitting position for 15 minutes and arterial blood oxygen saturation will be measured at the same time in the three organs earlobes, fingertips and the tip of toe. Then the the patient will be placed in the supine, prone and semi-sitting position and oxygen saturation will be measured in different organs at the same time.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The 22 Bahman hospital
Full name of responsible person
Samane Najafi
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Position
PhD in nursing education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Dr.Mohammadpour@gmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
S.Najafi2012@yahoo.com; Najafi.S@gmu.ac.ir; SamanehNajafi79@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Samane Najafi
Position
MSc in nursing education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan Razavi, Iran, Islamic Republic Of.
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
S.Najafi2012@yahoo.com; Najafi.S@gmu.ac.ir; SamanehNajafi79@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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