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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05118529
Other study ID # FoU i VGR:275466
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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