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

Mobilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05118529
• Other study ID #: FoU i VGR:275466
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• emergency admission to intensive care

• age >18 years

• understanding Swedish

Exclusion Criteria:

• Respiratory or circulatory instability where mobilization is contraindicated

Related Conditions & MeSH terms

• Intensive Care (ICU)
• Mobilization

Intervention

Other:
• Routine care
Mobilization to chair

Locations

Country	Name	City	State
Sweden	Göteborg University	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2	Arterial oxygen pressure	Within 8 hours after inclusion
Primary	PaCO2	Arterial carbon dioxide pressure	Within 8 hours after inclusion
Secondary	Blood pressure	Systolic and diastolic pressure	Within 8 hours after inclusion
Secondary	SpO2	Oxygen saturation	Within 8 hours after inclusion
Secondary	Perceived pain	Visual analogue scale from 0-100 mm	Within 8 hours after inclusion.
Secondary	Perceived exertion	Borg RPE scale from 6 to 20	Within 8 hours after inclusion
Secondary	Perceived satisfaction	Scale with 11 levels from 0 (no enjoyment) to 10 (maximum enjoyment).	Within 8 hours after inclusion
Secondary	Staff ratings of pain during mobilization	Visual analogue scale from 0-100 mm	Within 8 hours after inclusion
Secondary	Staff ratings of exertion during mobilization	Borg RPE scale from 6 to 20	Within 8 hours after inclusion