AzTrials
AzTrials

Intensive Care (ICU)NCT05118529

Physiological Response and Experience Between Sitting in Bed and Sitting in a Chair in ICU

A study testing Routine care in people with Intensive Care (ICU) and Mobilization, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: In the work with early mobilization (EM), in intensive care, several types of EM are used A sitting in bed in semi- Fowler's position, sitting on the edge of the bed, and sitting in a chair. Nowadays, it is often possible to achieve a comfortable sitting in the beds in ICU. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intensive Care (ICU), Mobilization
What is being tested?
Routine care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
1 Feb 2022to 30 Jun 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • emergency admission to intensive care
  • age >18 years
  • understanding Swedish

Who cannot join

  • Respiratory or circulatory instability where mobilization is contraindicated

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Göteborg University

    Gothenburg, 41345

Other trials in Sweden

About this study

Official title: Comparison of Physiological Response and Experience Between Sitting in Bed and Sitting in a Chair in Patients in Intensive Care

Background: In the work with early mobilization (EM), in intensive care, several types of EM are used A sitting in bed in semi- Fowler's position, sitting on the edge of the bed, and sitting in a chair. Nowadays, it is often possible to achieve a comfortable sitting in the beds in ICU. However, in a recent study by the same author group one of the findings was the importance to get out of bed. Getting out of bed was associated with decreasing feelings of hopelessness and being less ill. It also encouraged the will to fight for recovery.

There are few studies in intensive care that have examined what happens to circulation and oxygenation in various forms of sitting. Studies that examined the patient's own experience of sitting in bed compared to sitting in a chair are missing.

Read more

The aim is therefore to investigate physiological response and experience in patients in intensive care when sitting in bed or in a chair Method: Repeated measures randomized cross-over study Selection: Patients with respiratory and / or circulatory insufficiency requiring intensive care, Inclusion criteria: Approximately 30 respiratory and circulatory stable patients with emergency admission to intensive care. Aged over 18 years, who understands Swedish. The patient and / or relative are asked after the physician in charge has given medical approval. Recruitment is planned to be done by nurses in charge at the unit.

Exclusion criteria: Patients who have undergone planned surgery without complications.

Intervention: The participants in the study will be measured in two different positions; sitting in bed and sitting in chair. They are randomized to start either sitting in bed or in a chair and will sit for 20 minutes in each position, at 4 - hour intervals.

Data collection, physiological variables: The following physiological variables will be measured: Blood pressure and oxygenation by arterial needle and pulse by ECG. They will be measured before the intervention, at the beginning of the intervention, after ten minutes, at the end of the intervention and ten minutes afterwards Data collection, qualitative variables: Rating of the experience of exertion, pain and satisfaction.

Data analysis: Statistical analysis of differences between the two positions. For quantitative variables that are normally distributed, paired t-tests will be used. For qualitative variables and non-normally distributed quantitative variables, Wilcoxon character rank test or Mc Nemar test will be used

Being tested
Routine care
Keywords
Immobilization, Intensive Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine careOther

    Also called Mobilization in bed

    Mobilization to chair

Study groups in NCT05118529
Study groupRoleWhat they receive
Sitting in bedActive comparatorSitting in bed with 60 degrees elevated back-rest during 20 minutes
Receives: Other: Routine care
Sitting in chairExperimentalSitting in chair during 20 minutes
Receives: Other: Routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PaO2

    Arterial oxygen pressure

    Measured: Within 8 hours after inclusion

  2. PaCO2

    Arterial carbon dioxide pressure

    Measured: Within 8 hours after inclusion

Secondary outcomes (7)
  1. Blood pressure

    Systolic and diastolic pressure

    Measured: Within 8 hours after inclusion

  2. SpO2

    Oxygen saturation

    Measured: Within 8 hours after inclusion

  3. Perceived pain

    Visual analogue scale from 0-100 mm

    Measured: Within 8 hours after inclusion.

  4. Perceived exertion

    Borg RPE scale from 6 to 20

    Measured: Within 8 hours after inclusion

  5. Perceived satisfaction

    Scale with 11 levels from 0 (no enjoyment) to 10 (maximum enjoyment).

    Measured: Within 8 hours after inclusion

  6. Staff ratings of pain during mobilization

    Visual analogue scale from 0-100 mm

    Measured: Within 8 hours after inclusion

  7. Staff ratings of exertion during mobilization

    Borg RPE scale from 6 to 20

    Measured: Within 8 hours after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2021
  2. Study start1 Feb 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Routine care vs additional mobilization
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05118529
Sponsor's protocol ID
FoU i VGR:275466
Status last verified
Sep 2023
First submitted
18 Oct 2021
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Routine care in people with Intensive Care (ICU) and Mobilization, run by Göteborg University at 1 site in Sweden.

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 3 inclusion and 1 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 3 Oct 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 Sweden. 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?

PaO2 (time frame: Within 8 hours after inclusion). The study lists 2 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 3 Oct 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in