The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients Lying in the Supine Position

Sponsor

Uludag University (Other)

Overall Status

Completed

CT.gov ID

NCT06020768

Collaborator

(none)

Enrollment

Location

Arm

6.3

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroidectomy Colon Surgery Cholecystectomy Inguinal Hernia	Other: the bed-head was raised to an angle of 0, 20, 30 and 45 degrees	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Jul 23, 2022

Actual Study Completion Date :

Sep 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the different bed-head angles in the supine position The researcher brought the patient to the supine position with the bed-head at 0 degree, and immediately (minute 0) made haemodynamic measurements: central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation. It was taken into account that this could change haemodynamic parameters, and immediately after a 10-minute period of rest, the same haemodynamic measurements were repeated. After this, the bed-head was adjusted to an angle of 20 degree, and the same procedure was repeated, with measurements after 0 and 10 minutes. The same procedure was followed with the bed-head raised to 30 degree and then to 45 degree. In positioning the patients' bed-heads to different angles, a spirit level and a protractor were used.	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. Other Names: haemodynamic parameters were recorded

Arm

Intervention/Treatment

Experimental: the different bed-head angles in the supine position

The researcher brought the patient to the supine position with the bed-head at 0 degree, and immediately (minute 0) made haemodynamic measurements: central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation. It was taken into account that this could change haemodynamic parameters, and immediately after a 10-minute period of rest, the same haemodynamic measurements were repeated. After this, the bed-head was adjusted to an angle of 20 degree, and the same procedure was repeated, with measurements after 0 and 10 minutes. The same procedure was followed with the bed-head raised to 30 degree and then to 45 degree. In positioning the patients' bed-heads to different angles, a spirit level and a protractor were used.

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.

Other Names:

haemodynamic parameters were recorded

Outcome Measures

Primary Outcome Measures

central venous pressure [4 months]
central venous pressure in mmHg
blood pressure [4 months]
blood pressure pressure in mmHg
heart rate [4 months]
heart rate in beats
breathing rate [4 months]
breathing rate in breaths
peripheral oxygen saturation [4 months]
peripheral oxygen saturation in %

Secondary Outcome Measures

weight [4 months]
weight in kilograms
height [4 months]
height in meters
BMI [4 months]
BMI in kg/m^2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa Uludag University Hospital	Bursa	Nilüfer	Turkey	16059

Sponsors and Collaborators

Uludag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dilek Yilmaz, PhD, Associate Professor, Uludag University

ClinicalTrials.gov Identifier:

NCT06020768

Other Study ID Numbers:

2022-3/28

First Posted:

Sep 1, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dilek Yilmaz, PhD, Associate Professor, Uludag University

Intensive care units

haemodynamic parameters

central venous pressure

supine position

bed-head angle

Additional relevant MeSH terms:

Hernia, Inguinal

Study Results

No Results Posted as of Sep 1, 2023