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Completed

NCT Number: NCT05118529

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Göteborg University

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Respiratory or circulatory instability where mobilization is contraindicated

Treatment and study plan

Routine care

Other

Mobilization to chair

Other names: Mobilization in bed

Primary outcomes

  1. PaO2

    Time frame: Within 8 hours after inclusion

    Arterial oxygen pressure

  2. PaCO2

    Time frame: Within 8 hours after inclusion

    Arterial carbon dioxide pressure

Secondary outcomes

  1. Blood pressure

    Time frame: Within 8 hours after inclusion

    Systolic and diastolic pressure

  2. SpO2

    Time frame: Within 8 hours after inclusion

    Oxygen saturation

  3. Perceived pain

    Time frame: Within 8 hours after inclusion.

    Visual analogue scale from 0-100 mm

  4. Perceived exertion

    Time frame: Within 8 hours after inclusion

    Borg RPE scale from 6 to 20

  5. Perceived satisfaction

    Time frame: Within 8 hours after inclusion

    Scale with 11 levels from 0 (no enjoyment) to 10 (maximum enjoyment).

  6. Staff ratings of pain during mobilization

    Time frame: Within 8 hours after inclusion

    Visual analogue scale from 0-100 mm

  7. Staff ratings of exertion during mobilization

    Time frame: Within 8 hours after inclusion

    Borg RPE scale from 6 to 20

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2021
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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