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

NCT ID: NCT05118529

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-06-30

Brief 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. 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

Conditions

Intensive Care (ICU); Mobilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sitting in bed

Sitting in bed with 60 degrees elevated back-rest during 20 minutes

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: OTHER

Mobilization to chair

Sitting in chair

Sitting in chair during 20 minutes

Group Type: EXPERIMENTAL

Routine care

Intervention Type: OTHER

Mobilization to chair

Interventions

Routine care

Mobilization to chair

Intervention Type: OTHER

Other Intervention Names

Mobilization in bed

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Respiratory or circulatory instability where mobilization is contraindicated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Göteborg University

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

FoU i VGR:275466

Identifier Type: -

Identifier Source: org_study_id