Apparatus and Method for Moving Patients

NCT04882865 | Active Not Recruiting

• 1 other identifier: 30760
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Failure; Covid19

Keywords

prone ventilation; patient movement

Outcome Measures

Primary Outcomes (3)

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

  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

  6 months to 12 months

• 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)

  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

  6 months to 12 months

• 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

  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

  6 months to 12 months

Secondary Outcomes (1)

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

  6-12 months

Other Outcomes (1)

• perceptions of healthcare tram members of difficulties in handling patients

  3 months

Study Arms (3)

healthy volunteers as "patients"

use of the device (AMMP) and the process on 5 healthy volunteers undergoing proning, as well as "general care" (movement up or down the bed, rotated laterally). As well, repositioning sheets will be used for general care. Surveys of the impressions of team members of the value (ease of use, efficiency, safety, physical demands) of using the AMMP and the repositioning sheets with these "patients" will be completed. The impressions of the volunteers as patients will be surveyed, with particular reference to comfort and security during movement

Device: assist

ICU patients severe respiratory failure

patients with severe respiratory failure eligible for prone ventilation will be recruited with surveys provided to team members to gauge their impressions of the value of using the AMMP with the proning process for these patients. Surveys for 40 proning processes will be obtained. Movement from back to stomach or from stomach to back is considered a single process. A single patient may undergo multiple proning processes as prone ventilation is delivered for several days, with multiple healthcare team members participating in their care. We anticipate this will involve 10 patients, and 3 team members to be involved with each proning process.

Device: assist

Patients admitted to the ICU

40 patients will have the AMMP used for general care. An additional 40 will have repositioning sheets used for general care. Healthcare team members involved with the care of these patients will be surveyed re their impressions of the value of using the AMMP or the repositioning sheets. We cannot predict the number of healthcare team members involved with the care of each patient s because of clinical conditions and length of stay

Device: assist

Interventions

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

ICU patients severe respiratory failure; Patients admitted to the ICU; healthy volunteers as "patients"

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Qe Ii Hsc

Halifax, Nova Scotia, B3h2y9, Canada

Location

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 12, 2021
• Study Start: May 15, 2021
• Primary Completion: May 15, 2025
• Study Completion: February 15, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)