Position Sense DisordersNCT06538051
The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.
A study testing lying positions in people with Position Sense Disorders and Hemodynamic Instability, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing. Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Position Sense Disorders, Hemodynamic Instability
- What is being tested?
- lying positions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 May 2022
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in intensive care for at least 3 days
- over 18 years of age
- monitored
- spontaneously breathing or connected to a mechanical ventilator,
- conscious or unconscious,
- receiving or not receiving oxygen support,
- with or without a tracheostomy,
- hemoglobin level of 8g/dl.
Who cannot join
- Patients with movement restrictions
- inotropic/vasopressor and sedative group medications
- body temperature of 38˚C and above
- patients receiving CPAP (Continuous Positive Airway Pressure) treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lying Positions on Hemodynamic Parameters in Intensive Care Patients
Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.
Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. The study of the sample consisted of 60 patients in the ICU. Data were collected with the patient identification form and the hemodynamic parameters follow-up form. The patients were given different lying positions for 3 days. Hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. The measurement results obtained were compared with one-way ANOVA test.
Read the detailed description
Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.
Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between the dates of 15.11.2021 and 15.05.2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. Since repeated measurements were planned in the study when determining the sample, A-priori power analysis was performed based on ANOVA repeated measures analysis and the effect size was calculated according to the etasquared value (Abd El-Aziz et al., 2021). Accordingly, the sample of the study was calculated as 34 patients to reach at least 80% power within a 95% confidence interval. The research was completed with a total of 60 patients who were spontaneously breathing (n=30) and mechanically ventilated (n=30). Data were collected with the patient identification form and the hemodynamic parameters follow-up form. Right lateral, semi Fowler's, left lateral and supine positions were applied to the patients every 2 hours between 9 am 5 pm for 3 days and then pulse rate, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation (SpO₂) were measured at 10th minute, 1st hour and 2nd hour. In data analysis, number, arithmetic mean, standard deviation, chi-square, independent groups t test and one-way ANOVA test were used.
- Conditions
- Position Sense Disorders, Hemodynamic Instability
- Being tested
- lying positions
- Keywords
- Patient position, nurse, Hemodynamic parameter, Intensive care unit
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lying positionsOther
All patients were placed in supine, semi-fowler's and lateral positions, respectively. The effects of positions on hemodynamic parameters were examined.
| Study group | Role | What they receive |
|---|---|---|
| lying positions | Other | Not described Receives: Other: lying positions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
The patients' respiratory rate were measured and compared separately in the supine semi-fowler's and lateral positions.
Measured: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
oxygen saturation
The patients' oxygen saturation were measured and compared separately in the supine semi-fowler's and lateral positions.
Measured: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
Arterial blood pressure
The patients' arterial blood pressure were measured and compared separately in the supine semi-fowler's and lateral positions.
Measured: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
pulse rate
The patients' pulse rate were measured and compared separately in the supine semi-fowler's and lateral positions.
Measured: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Nov 2021
- Primary completion15 Nov 2021
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Position Sense DisordersStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Olğun, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538051
- Sponsor's protocol ID
- position
- Status last verified
- Jun 2024
- First submitted
- 1 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lying Positions on Hemodynamic Parameters in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06538051
- Acronym / sponsor ID
- position
- Conditions
- Position Sense Disorders, Hemodynamic Instability
- Keywords
- Patient position, nurse, Hemodynamic parameter, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 5 Aug 2024 (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.
Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.
Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. The study of the sample consisted of 60 patients in the ICU. Data were collected with the patient identification form and the hemodynamic parameters follow-up form. The patients were given different lying positions for 3 days. Hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. The measurement results obtained were compared with one-way ANOVA test.
Detailed description
Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.
Material and Methods: The research was carried out semi-experimentally with a single-group posttest design, between the dates of 15.11.2021 and 15.05.2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. Since repeated measurements were planned in the study when determining the sample, A-priori power analysis was performed based on ANOVA repeated measures analysis and the effect size was calculated according to the etasquared value (Abd El-Aziz et al., 2021). Accordingly, the sample of the study was calculated as 34 patients to reach at least 80% power within a 95% confidence interval. The research was completed with a total of 60 patients who were spontaneously breathing (n=30) and mechanically ventilated (n=30). Data were collected with the patient identification form and the hemodynamic parameters follow-up form. Right lateral, semi Fowler's, left lateral and supine positions were applied to the patients every 2 hours between 9 am 5 pm for 3 days and then pulse rate, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation (SpO₂) were measured at 10th minute, 1st hour and 2nd hour. In data analysis, number, arithmetic mean, standard deviation, chi-square, independent groups t test and one-way ANOVA test were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lying positions | Other | Other: lying positions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hospitalized in intensive care for at least 3 days
- over 18 years of age
- monitored
- spontaneously breathing or connected to a mechanical ventilator,
- conscious or unconscious,
Key exclusion criteria (4 listed)
- Patients with movement restrictions
- inotropic/vasopressor and sedative group medications
- body temperature of 38˚C and above
- patients receiving CPAP (Continuous Positive Airway Pressure) treatment
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 |
|---|---|---|
| lying positionsAll patients were placed in supine, semi-fowler's and lateral positions, respectively. The effects of positions on hemodynamic parameters were examined. | Other | lying positions |
Primary outcome
Respiratory rate
Time frame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
The patients' respiratory rate were measured and compared separately in the supine semi-fowler's and lateral positions.
oxygen saturation
Time frame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
The patients' oxygen saturation were measured and compared separately in the supine semi-fowler's and lateral positions.
Arterial blood pressure
Time frame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
The patients' arterial blood pressure were measured and compared separately in the supine semi-fowler's and lateral positions.
pulse rate
Time frame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
The patients' pulse rate were measured and compared separately in the supine semi-fowler's and lateral 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 5 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lying positions in people with Position Sense Disorders and Hemodynamic Instability, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 8 inclusion and 4 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Respiratory rate (time frame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.). The study lists 4 primary outcomes in all. 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 5 Aug 2024.