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Active, Not Recruiting

NCT Number: NCT04882865

Apparatus and Method for Moving Patients

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Respiratory Failure COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qe Ii Hsc

Halifax, Nova Scotia, B3h2y9, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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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Treatment and study plan

assist

Device

A custom designed patient wrap will envelope the patient. This will be coupled to a mechanical lift system to facilitate repositioning of the patient (AMMP) Commercially available repositioning sheets will be used for the general care of some study patients

Primary outcomes

  1. Perception of the experience of "healthy volunteers as patients" when moved by a healthcare team utilizing a novel device (AMMP) or repositioning sheets.

    Time frame: 6 months to 12 months

    The AMMP will be used to move volunteers for "general care" (up or down the bed, into lateral position) or into prone position. The repositioning sheets will be used to move volunteers for "general care". Repositioning sheets are not designed to be used for prone positioning Qualitiative surveys of the "patient" experience utilizing a survey tool with a 5 point Likert scale will be used focused on their perceptions of comfort, anxiety related to the movement and feelings of feeling security as well as open narrative

  2. 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)

    Time frame: 6 months to 12 months

    Repositioning sheets and the AMMP will be used by healthcare team members to facilitate patient handling for general care of ICU patient in an ICU where this type of movement aid has not been previously utilized. Qualitiative review of team members impressions of the feasibility of the use of this device for this purpose will be assessed utilizing surveys with 5 point Likert scale as well as open narrative. Team members impressions of the use of this aid, compared to the AMMP for general care and to their impressions of the provision of general care without the use of aids will be assessed in the survey tool

  3. 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

    Time frame: 6 months to 12 months

    A novel apparatus and method to reposition patients ( AMMP) has been developed. Perceptions of team members using this to move ICU patients from supine to prone, or prone to supine, during therapy for severe respiratory failure, will be assessed relative to traditional approaches to movement of patients without aids. A quantitative analysis of perceptions across multiple dimensions (ease of use of the device, efficiency, physical demand for healthcare team member, adverse effects on patients) will be undertaken utilizing a survey instrument with a 5 point Likert scale as well as open narrative

Secondary outcomes

  1. Economic analysis of the use of the AMMP for ICU patients requiring prone ventilation

    Time frame: 6-12 months

    Movement of patients from supine to prone or prone to supine to facilitate mechanical ventilation for patients with severe lung disease is resource intensive (requirement for personal protective equipment (PPE)) , dependant on a large team (5-7 people) and time intensive. A comparison of the efficiency of patient movement with the AMMP relative to movement without an aid will be completed. Historical values for time to complete, number of personnel needed to complete and the number of sets of PPE for this process will be compared to these parameters when the AMMP is used. Personnel costs (number of people x cost per hour x total time taken) and resource utilization ( number of sets of PPE x cost /set of PPE) added together will define "total costs" for this comparison

Other outcomes

  1. perceptions of healthcare tram members of difficulties in handling patients

    Time frame: 3 months

    Non ambulatory patients must move, or be moved, to recover. Healthcare team members frequently must assist, which is physically demanding, putting team members at risk of injury. The concerns of healthcare team members in the acute care ( ICU) will be surveyed to collate and quantify their role in the healthcare team, their experience with patient handling, opinions on ideal team size for patient handling, and injury history associated with patient handling

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study 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

Acronym: AMMP

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 12, 2021
Registry last updated
Aug 21, 2024

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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