Positions and Peripheral Oxygen Saturation

March 13, 2017 updated by: Leyla Khorshitd, Ege University

Comparison of Five Different Positions on Peripheral Oxygen Saturation and Vital Signs in Patients With Lung Disease

The subjects were placed consecutively in random order in the five different positions 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who were over 18 years of age and who were able to lie in all positions, and who had right lung disease (n=20), left lung disease (n=21) or bilateral lung disease (n=68) documented by medical diagnosis by a physician were included in this descriptive study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
lung disease
Patients with lung disease
Other: position
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Leyla KHORSHTD, Prof. Dr., Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013/44-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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