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NCT Number: NCT06538051

The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.

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.

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Key information

Conditions

Position Sense Disorders Hemodynamic Instability Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sevil Olğun

Aydin, 09010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lying positions

Other

All patients were placed in supine, semi-fowler's and lateral positions, respectively. The effects of positions on hemodynamic parameters were examined.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effect of Lying Positions on Hemodynamic Parameters in Intensive Care Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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