Lung DiseasesNCT03083223
Positions and Peripheral Oxygen Saturation
An observational study of Lung Diseases, run by Ege University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- position
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2013to 15 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who have not accepted to participate.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- position
- Keywords
- patient positioning, lung diseases, oxygenation, hemodynamic parameters, vital signs
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| lung disease | Patients with lung disease Receives: Other: position |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation in different positions
SaO2 in each of the five positions
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start12 May 2013
- Primary completion10 Dec 2013
- Study completion15 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Khorshitd, Ege University
- Investigators
- Leyla KHORSHTD, Prof. Dr., Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083223
- Sponsor's protocol ID
- 2013/44-19
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Five Different Positions on Peripheral Oxygen Saturation and Vital Signs in Patients With Lung Disease
- ClinicalTrials.gov ID
- NCT03083223
- Acronym / sponsor ID
- 2013/44-19
- Conditions
- Lung Diseases
- Keywords
- patient positioning, lung diseases, oxygenation, hemodynamic parameters, vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 12 May 2013 (actual)
- Primary completion
- 10 Dec 2013 (actual)
- Study completion
- 15 Sep 2015 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung disease | – | Other: positionPatients with lung disease |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who have not accepted to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positionSubjects 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. | Other | lung disease |
Primary outcome
oxygen saturation in different positions
Time frame: an average of 1 year
SaO2 in each of the five positions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla KHORSHTD, Prof. Dr. study director
Ege University
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen saturation in different positions (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.