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

NCT05118529 | Completed

• 1 other identifier: FoU i VGR:275466
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Immobilization; Intensive Care

Outcome Measures

Primary Outcomes (2)

• PaO2

  Arterial oxygen pressure

  Within 8 hours after inclusion

• PaCO2

  Arterial carbon dioxide pressure

  Within 8 hours after inclusion

Secondary Outcomes (7)

• Blood pressure

  Within 8 hours after inclusion

• SpO2

  Within 8 hours after inclusion

• Perceived pain

  Within 8 hours after inclusion.

• Perceived exertion

  Within 8 hours after inclusion

• Perceived satisfaction

  Within 8 hours after inclusion

Study Arms (2)

Sitting in bed

ACTIVE COMPARATOR

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

Other: Routine care

Sitting in chair

EXPERIMENTAL

Sitting in chair during 20 minutes

Other: Routine care

Interventions

Routine care OTHER

Mobilization to chair

Also known as: Mobilization in bed

Sitting in bed; Sitting in chair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Respiratory or circulatory instability where mobilization is contraindicated

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Göteborg University

Gothenburg, 41345, Sweden

Location

MeSH Terms

Interventions

Beds

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Routine care vs additional mobilization

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 12, 2021
• Study Start: February 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

SE (1)