NCT06020768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 26, 2023

Last Update Submit

August 26, 2023

Conditions

Keywords

Intensive care unitshaemodynamic parameterscentral venous pressuresupine positionbed-head angle

Outcome Measures

Primary Outcomes (5)

  • central venous pressure

    central venous pressure in mmHg

    4 months

  • blood pressure

    blood pressure pressure in mmHg

    4 months

  • heart rate

    heart rate in beats

    4 months

  • breathing rate

    breathing rate in breaths

    4 months

  • peripheral oxygen saturation

    peripheral oxygen saturation in %

    4 months

Secondary Outcomes (3)

  • weight

    4 months

  • height

    4 months

  • BMI

    4 months

Study Arms (1)

the different bed-head angles in the supine position

EXPERIMENTAL

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

Interventions

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.

Also known as: haemodynamic parameters were recorded
the different bed-head angles in the supine position

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University Hospital

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, InguinalDeception

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 1, 2023

Study Start

March 1, 2022

Primary Completion

July 23, 2022

Study Completion

September 10, 2022

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations