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.
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.
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
- Conditions
- Intensive Care (ICU), Mobilization
- 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 group | Role | What they receive |
|---|---|---|
| Sitting in bed | Active comparator | Sitting in bed with 60 degrees elevated back-rest during 20 minutes Receives: Other: Routine care |
| Sitting in chair | Experimental | Sitting 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.
PaO2
Arterial oxygen pressure
Measured: Within 8 hours after inclusion
PaCO2
Arterial carbon dioxide pressure
Measured: Within 8 hours after inclusion
Secondary outcomes (7)
Blood pressure
Systolic and diastolic pressure
Measured: Within 8 hours after inclusion
SpO2
Oxygen saturation
Measured: Within 8 hours after inclusion
Perceived pain
Visual analogue scale from 0-100 mm
Measured: Within 8 hours after inclusion.
Perceived exertion
Borg RPE scale from 6 to 20
Measured: Within 8 hours after inclusion
Perceived satisfaction
Scale with 11 levels from 0 (no enjoyment) to 10 (maximum enjoyment).
Measured: Within 8 hours after inclusion
Staff ratings of pain during mobilization
Visual analogue scale from 0-100 mm
Measured: Within 8 hours after inclusion
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.
- First posted12 Nov 2021
- Study start1 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Routine care vs additional mobilization
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physiological Response and Experience Between Sitting in Bed and Sitting in a Chair in Patients in Intensive Care
- ClinicalTrials.gov ID
- NCT05118529
- Acronym / sponsor ID
- FoU i VGR:275466
- Conditions
- Intensive Care (ICU), Mobilization
- Keywords
- Immobilization, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Nov 2021 (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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Routine care vs additional mobilization
| Arm | Type | Receives |
|---|---|---|
| Sitting in bed | Active comparator | Other: Routine careSitting in bed with 60 degrees elevated back-rest during 20 minutes |
| Sitting in chair | Experimental | Other: Routine careSitting in chair during 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- emergency admission to intensive care
- age >18 years
- understanding Swedish
Key exclusion criteria (1 listed)
- Respiratory or circulatory instability where mobilization is contraindicated
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 |
|---|---|---|
| Routine careAlso: Mobilization in bedMobilization to chair | Other | Sitting in bed, Sitting in chair |
Primary outcome
PaO2
Time frame: Within 8 hours after inclusion
Arterial oxygen pressure
PaCO2
Time frame: Within 8 hours after inclusion
Arterial carbon dioxide pressure
7 secondary outcomes
Blood pressure
Time frame: Within 8 hours after inclusion
SpO2
Time frame: Within 8 hours after inclusion
Perceived pain
Time frame: Within 8 hours after inclusion.
Perceived exertion
Time frame: Within 8 hours after inclusion
Perceived satisfaction
Time frame: Within 8 hours after inclusion
Staff ratings of pain during mobilization
Time frame: Within 8 hours after inclusion
Staff ratings of exertion during mobilization
Time frame: Within 8 hours after inclusion
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 3 Oct 2023.
Related trials for Intensive Care (ICU)
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
Not yet recruiting
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
Cardiac Surgery
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
Not yet recruiting
Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever
Fever, Temperature Monitoring
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 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.