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

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.

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 Overview

• Status: Completed
• Conditions: Mobilization; Intensive Care (ICU)
• Intervention / Treatment: Other: Routine care

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Göteborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Respiratory or circulatory instability where mobilization is contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sitting in bed; Sitting in bed with 60 degrees elevated back-rest during 20 minutes	Other: Routine care; Mobilization to chair; Other Names: Mobilization in bed
Experimental: Sitting in chair; Sitting in chair during 20 minutes	Other: Routine care; Mobilization to chair; Other Names: Mobilization in bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2	Arterial oxygen pressure	Within 8 hours after inclusion
PaCO2	Arterial carbon dioxide pressure	Within 8 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic pressure	Within 8 hours after inclusion
SpO2	Oxygen saturation	Within 8 hours after inclusion
Perceived pain	Visual analogue scale from 0-100 mm	Within 8 hours after inclusion.
Perceived exertion	Borg RPE scale from 6 to 20	Within 8 hours after inclusion
Perceived satisfaction	Scale with 11 levels from 0 (no enjoyment) to 10 (maximum enjoyment).	Within 8 hours after inclusion
Staff ratings of pain during mobilization	Visual analogue scale from 0-100 mm	Within 8 hours after inclusion
Staff ratings of exertion during mobilization	Borg RPE scale from 6 to 20	Within 8 hours after inclusion

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care; Immobilization
• Other Study ID Numbers: FoU i VGR:275466

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No