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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06020768
Other study ID # 2022-3/28
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date September 10, 2022

Study information

Verified date August 2023
Source Uludag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: The aim of this study was to examine the effect of different bed-head angles given to patients lying in the supine position in an intensive care unit on the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation. Methods: The study was conducted with 50 intensive care patients aged 18 and over in a general surgery intensive care unit in Turkey. With each patient in the supine position, the bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10 minutes.


Description:

Aim: The aim of this study was to examine the effect of different bed-head angles given to patients lying in the supine position in an intensive care unit on the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation. Design: This was a non-randomised quasi-experimental repeated measures study. Settings: The study was conducted with 50 intensive care patients aged 18 and over in a general surgery intensive care unit in Turkey. Methods: With each patient in the supine position, the bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10 minutes. The data obtained was evaluated using the Mann-Whitney test, the Kruskal Wallis test and the Bonferroni test.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 10, 2022
Est. primary completion date July 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - participating voluntarily in the study - being aged over 18 years, - having stayed in the General Surgery Intensive Care Unit for at least 24 hours, - being monitored for 24 hours, - having a central venous catheter inserted, - having central venous pressure measured. Exclusion Criteria: - being less than 18 years of age, - not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study, - receiving sedation treatment, - receiving haemodialysis treatment, - having an oxygen saturation value of less than 90%, - being unable to tolerate a 0° prone position (hypovolemic or bradycardic).

Study Design


Intervention

Other:
the bed-head was raised to an angle of 0, 20, 30 and 45 degrees
With each patient in the supine position, the bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10 minutes.

Locations

Country Name City State
Turkey Bursa Uludag University Hospital Bursa Nilüfer

Sponsors (1)

Lead Sponsor Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary central venous pressure central venous pressure in mmHg 4 months
Primary blood pressure blood pressure pressure in mmHg 4 months
Primary heart rate heart rate in beats 4 months
Primary breathing rate breathing rate in breaths 4 months
Primary peripheral oxygen saturation peripheral oxygen saturation in % 4 months
Secondary weight weight in kilograms 4 months
Secondary height height in meters 4 months
Secondary BMI BMI in kg/m^2 4 months
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