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

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ClinicalTrials.gov Identifier: NCT06020768
Recruitment Status : Completed
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Dilek Yilmaz, PhD, Uludag University

Study Description
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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 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2022
Actual Primary Completion Date : July 23, 2022
Actual Study Completion Date : September 10, 2022
Arms and Interventions
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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 Name: haemodynamic parameters were recorded


Outcome Measures
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Primary Outcome Measures :
  1. central venous pressure [ Time Frame: 4 months ]
    central venous pressure in mmHg

  2. blood pressure [ Time Frame: 4 months ]
    blood pressure pressure in mmHg

  3. heart rate [ Time Frame: 4 months ]
    heart rate in beats

  4. breathing rate [ Time Frame: 4 months ]
    breathing rate in breaths

  5. peripheral oxygen saturation [ Time Frame: 4 months ]
    peripheral oxygen saturation in %


Secondary Outcome Measures :
  1. weight [ Time Frame: 4 months ]
    weight in kilograms

  2. height [ Time Frame: 4 months ]
    height in meters

  3. BMI [ Time Frame: 4 months ]
    BMI in kg/m^2


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020768


Locations
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Turkey
Bursa Uludag University Hospital
Bursa, Nilüfer, Turkey, 16059
Sponsors and Collaborators
Uludag University
More Information
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Responsible Party: Dilek Yilmaz, PhD, Associate Professor, Uludag University
ClinicalTrials.gov Identifier: NCT06020768    
Other Study ID Numbers: 2022-3/28
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilek Yilmaz, PhD, Uludag University:
Intensive care units
haemodynamic parameters
central venous pressure
supine position
bed-head angle
Additional relevant MeSH terms:
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Hernia, Inguinal
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal