- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03083223
Positions and Peripheral Oxygen Saturation
Comparison of Five Different Positions on Peripheral Oxygen Saturation and Vital Signs in Patients With Lung Disease
Study Overview
Detailed Description
The semi-seated position in bed at 45°: SSPB-45° The semi-seated position in bed at 60° :SSPB-60° Seated position in bed at 90°: SPB-90° Lying on the right side of the body at 45°: LRSB-45° , Lying on the left side of the body at 45°: LLSB-45°
A questionnaire which consisted of a Subjects' Introduction Form and a Vital Signs-SaO2 Record Form was used in collecting the data.
The subjects were placed consecutively in random order in the five different positions, SSPB-45°, SSPB-60°, SPB-90°, LRSB-45°, and LLSB-45°, by drawing lots. Oxygen saturation (SaO2) and vital signs (pulse rate, respiratory rate, systolic blood pressure, diastolic blood pressure and body temperature) were measured in each position at 10, 25 and 40 minutes. Oxygen saturation and vital signs were measured with a finger pulse oximeter (Nellcor N-560). Nail polish was removed before measurement of oxygen saturation, and if there was any physical restraint on subjects it was removed. Body temperature was measured via the ear with a tympanic membrane thermometer (Covidiev Genius 2). Systolic and diastolic blood pressure were measured with a calibrated sphygmomanometer from the left arm with the same sphygmomanometer (Erka aneroid sphygmomanometer®) and stethoscope. Pulse rate and respiratory rate were manually monitored for a period of one minute by the researcher using a wristwatch. Verbal and written informed consent was obtained from the subjects or from their closest relatives.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects who were over 18 years of age and who are able to lie in all positions, and who had unilateral/or bilateral lung disease documented by medical diagnosis by a physician were included in this study.
- Patients who accepted to participated to the study.
Exclusion Criteria:
- Patients who have not accepted to participate.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
lung disease
Patients with lung disease
|
Subjects were placed consecutively in random order in five different positions.
SaO2 and vital signs were measured at each position after 10, 25, and 40 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oxygen saturation in different positions
Time Frame: an average of 1 year
|
SaO2 in each of the five positions
|
an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Leyla KHORSHTD, Prof. Dr., Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/44-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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