- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06538051
The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aydın, Turkey, 09010
- Sevil Olğun
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: lying positions
|
All patients were placed in supine, semi-fowler's and lateral positions, respectively.
The effects of positions on hemodynamic parameters were examined.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
|
|
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.
|
Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
|
|
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.
|
Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
|
|
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.
|
Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- position
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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