Clinical trial NCT04882865: Apparatus and Method for Moving Patients
Official title: Apparatus and Method for Moving Patients: Users Impressions of the Use of a Novel Device to Assist With Patient Movement as Compared to Repositioning Sheets
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiratory Failure
Covid19
Keywords: prone ventilation
patient movement
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 191
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult (\>16y) patients admitted to the Med- Surg Neuro ICU at the Queen Elizabeth II Health Science Centre, including those with severe respiratory failure.

Brief summary: A novel device and process to move patients has been developed, particularly useful for patients with severe respiratory failure (ie COVID 19) who require prone ventilation (moving from their back onto the stomach and then onto back for a 16 hour cycle, usually for several days).

This study will assess staff impressions of the feasibility of the use of this device/ process to prone patients as well as their impressions of the use of this device, compared to repositioning sheets, for the general care of the ICU patient. An economic analysis of the use of the AMMP for proning compared to movement without assists will be done

Detailed description: Movement of non ambulatory patients is typically a physically demanding, resource intensive intervention that places the healthcare team members at risk of injury. A quantitative survey of healthcare team members perspectives on the challenges associated with patient movement will be distributed.

This is particularly true for caregivers responsible for severely ill respiratory failure patients (ie COVID 19) who are moved into prone position (flipped on to their stomach) and back to supine over a 16 hour cycle, typically repeated for several days, as part of their therapy. (proning) A method of wrapping the patient in a secure "cocoon" which is coupled to a mechanical lift system through a designed strapping system and support bar will be tested for proning on healthy volunteers and then in the clinical environment ( intensive care unit (ICU) . Healthcare team members will complete surveys to assess ease of use, efficiency, safety and physical demands of this process relative to traditional (control) manual methods of patient reorientation, without the use of assists for proning.

Critically ill nonambulatory patients require assistance to move. The AMMP can be used to assist and impressions of this device. Comparing the impressions of healthcare team members of the use of the AMMP, repositioning sheets, and to care without the use of a movement assistance device will be undertaken using quantitative surveys An economic analysis of the use of the AMMP to prone patients, focused on personnel time and personal protective equipment use, compared to proning without assistance, will be completed

Eligibility criteria: Inclusion Criteria:any adult ICU patient is eligible for enrolment in assessment of health care team members impressions of the use of repositioning sheets for general care ( movement up or down the bed or in to lateral position) Adult ICU patients admitted to the ICU with severe respiratory failure (PaO2/FiO2 ratio \<150) are candidates for use of the AMMP for prone positioning unless exclusion criteria are present Adult ICU patients requiring general care are candidates for use of the AMMP for general care unless exclusion criteria are present -

Exclusion Criteria:discretion of ICU attending, unable to obtain consent, unstable spine fracture, chest tube drainage in place, open abdomen, \>140 kg

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Primary outcomes:
measure: Perception of the experience of "healthy volunteers as patients" when moved by a healthcare team utilizing a novel device (AMMP) or repositioning sheets.
timeFrame: 6 months to 12 months
measure: Perception of healthcare team members of the use of repositioning sheets and the AMMP to assist with patient handling of ICU patients requiring general care ( movement up or down the bed, into lateral position)
timeFrame: 6 months to 12 months
measure: Perception of healthcare team members of the use of a novel process to assist with patient handling in the ICU, in particular for movement into prone position
timeFrame: 6 months to 12 months
Secondary outcomes:
measure: Economic analysis of the use of the AMMP for ICU patients requiring prone ventilation
timeFrame: 6-12 months
Other outcomes:
measure: perceptions of healthcare tram members of difficulties in handling patients
timeFrame: 3 months
Locations:
city: Halifax
country: Canada
facility: Qe Ii Hsc
state: Nova Scotia
Study officials:
References: