ThyroidectomyNCT06020768
The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients Lying in the Supine Position
A study testing the bed-head was raised to an angle of 0, 20, 30 and 45 degrees in people with Thyroidectomy and Colon Surgery, run by Uludag University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroidectomy, Colon Surgery, Cholecystectomy
- What is being tested?
- the bed-head was raised to an angle of 0, 20, 30 and 45 degrees
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University Hospital
Bursa, Nilüfer, 16059
About this study
Official title: The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients
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.
Read the 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.
- Conditions
- Thyroidectomy, Colon Surgery, Cholecystectomy, Inguinal Hernia
- Being tested
- the bed-head was raised to an angle of 0, 20, 30 and 45 degrees
- Keywords
- Intensive care units, haemodynamic parameters, central venous pressure, supine position, bed-head angle
- Medical subject headings
- Hernia, Inguinal, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the bed-head was raised to an angle of 0, 20, 30 and 45 degreesOther
Also called haemodynamic parameters were recorded
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: the bed-head was raised to an angle of 0, 20, 30 and 45 degrees |
What is being measured
The primary outcome is the main question the study is designed to answer.
central venous pressure
central venous pressure in mmHg
Measured: 4 months
blood pressure
blood pressure pressure in mmHg
Measured: 4 months
heart rate
heart rate in beats
Measured: 4 months
breathing rate
breathing rate in breaths
Measured: 4 months
peripheral oxygen saturation
peripheral oxygen saturation in %
Measured: 4 months
Secondary outcomes (3)
weight
weight in kilograms
Measured: 4 months
height
height in meters
Measured: 4 months
BMI
BMI in kg/m^2
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Mar 2022
- Primary completion23 Jul 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020768
- Sponsor's protocol ID
- 2022-3/28
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06020768
- Acronym / sponsor ID
- 2022-3/28
- Conditions
- Thyroidectomy, Colon Surgery, Cholecystectomy, Inguinal Hernia
- Keywords
- Intensive care units, haemodynamic parameters, central venous pressure, supine position, bed-head angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 23 Jul 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the different bed-head angles in the supine position | Experimental | Other: the bed-head was raised to an angle of 0, 20, 30 and 45 degreesThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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%,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the bed-head was raised to an angle of 0, 20, 30 and 45 degreesAlso: haemodynamic parameters were recordedWith 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 | the different bed-head angles in the supine position |
Primary outcome
central venous pressure
Time frame: 4 months
central venous pressure in mmHg
blood pressure
Time frame: 4 months
blood pressure pressure in mmHg
heart rate
Time frame: 4 months
heart rate in beats
breathing rate
Time frame: 4 months
breathing rate in breaths
peripheral oxygen saturation
Time frame: 4 months
peripheral oxygen saturation in %
3 secondary outcomes
weight
Time frame: 4 months
height
Time frame: 4 months
BMI
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the bed-head was raised to an angle of 0, 20, 30 and 45 degrees in people with Thyroidectomy and Colon Surgery, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central venous pressure (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.