Apparatus and Method for Moving Patients

NCT ID: NCT04882865

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 191 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2026-02-15

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

Conditions

Respiratory Failure; Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

assist

Intervention Type: 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 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.

assist

Intervention Type: 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

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

assist

Intervention Type: 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

Interventions

assist

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

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qe Ii Hsc

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

30760

Identifier Type: -

Identifier Source: org_study_id