search
Back to results

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

Primary Purpose

Thyroidectomy, Colon Surgery, Cholecystectomy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
the bed-head was raised to an angle of 0, 20, 30 and 45 degrees
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroidectomy focused on measuring Intensive care units, haemodynamic parameters, central venous pressure, supine position, bed-head angle

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Bursa Uludag University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the different bed-head angles in the supine position

Arm Description

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.

Outcomes

Primary Outcome Measures

central venous pressure
central venous pressure in mmHg
blood pressure
blood pressure pressure in mmHg
heart rate
heart rate in beats
breathing rate
breathing rate in breaths
peripheral oxygen saturation
peripheral oxygen saturation in %

Secondary Outcome Measures

weight
weight in kilograms
height
height in meters
BMI
BMI in kg/m^2

Full Information

First Posted
August 26, 2023
Last Updated
August 26, 2023
Sponsor
Uludag University
search

1. Study Identification

Unique Protocol Identification Number
NCT06020768
Brief Title
The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients Lying in the Supine Position
Official Title
The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 23, 2022 (Actual)
Study Completion Date
September 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Colon Surgery, Cholecystectomy, Inguinal Hernia
Keywords
Intensive care units, haemodynamic parameters, central venous pressure, supine position, bed-head angle

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the different bed-head angles in the supine position
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
the bed-head was raised to an angle of 0, 20, 30 and 45 degrees
Other Intervention Name(s)
haemodynamic parameters were recorded
Intervention Description
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.
Primary Outcome Measure Information:
Title
central venous pressure
Description
central venous pressure in mmHg
Time Frame
4 months
Title
blood pressure
Description
blood pressure pressure in mmHg
Time Frame
4 months
Title
heart rate
Description
heart rate in beats
Time Frame
4 months
Title
breathing rate
Description
breathing rate in breaths
Time Frame
4 months
Title
peripheral oxygen saturation
Description
peripheral oxygen saturation in %
Time Frame
4 months
Secondary Outcome Measure Information:
Title
weight
Description
weight in kilograms
Time Frame
4 months
Title
height
Description
height in meters
Time Frame
4 months
Title
BMI
Description
BMI in kg/m^2
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Bursa Uludag University Hospital
City
Bursa
State/Province
Nilüfer
ZIP/Postal Code
16059
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs