Respiratory FailureAMMPNCT04882865
Apparatus and Method for Moving Patients
An observational study of Respiratory Failure and Covid19, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Covid19
- What is being tested?
- assist
- Type of treatment
- Medical device
- How many people
- 191 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2021to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- assist
- Keywords
- prone ventilation, patient movement
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assistDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Device: assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months to 12 months
Secondary outcomes (1)
Economic analysis of the use of the AMMP for ICU patients requiring prone ventilation
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
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start15 May 2021
- Primary completion15 May 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882865
- Sponsor's protocol ID
- 30760
- Acronym
- AMMP
- Status last verified
- Aug 2024
- First submitted
- 4 May 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04882865
- Acronym / sponsor ID
- AMMP / 30760
- Conditions
- Respiratory Failure, Covid19
- Keywords
- prone ventilation, patient movement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers as "patients" | – | Device: assistuse 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 |
| ICU patients severe respiratory failure | – | Device: assistpatients 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. |
| Patients admitted to the ICU | – | Device: assist40 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assistA 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 | Device | ICU patients severe respiratory failure, Patients admitted to the ICU, healthy volunteers as "patients" |
Primary outcome
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
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
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
1 secondary outcome
Economic analysis of the use of the AMMP for ICU patients requiring prone ventilation
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Covid19, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.