Clinical trial NCT06538051: The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.
Official title: The Effect of Lying Positions on Hemodynamic Parameters in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Position Sense Disorders
Hemodynamic Instability
Keywords: Patient position
nurse
Hemodynamic parameter
Intensive care unit
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory rate
timeFrame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
measure: oxygen saturation
timeFrame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
measure: Arterial blood pressure
timeFrame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
measure: pulse rate
timeFrame: Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Sevil Olğun
Study officials:
References: