Air Suspension Biodegradable Patient Transport Pad

NCT03858374 | Unknown

• 1 other identifier: 2018PY011
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

On the one hand, transferring patient from bed to bed is usually handling by the manual lifting of several staffs or utilizing bedsheet, slide sheet , shovel-style stretcher or other devices to move and lift patients. Whatever, there are some advantages using these devices. On the other hand, nurses are among the professionals at the highest risk for musculoskeletal disorders. The Bureau of Labor Statistics has shown that overexertion in manual lifting was the main event or exposure leading to injury or illness involving time away from work. Excessive weights, awkward postures, and repetitive motions are some of the known risk factors that contribute to sprains/strains and back injuries. During the process of patient transferring , it refers to the above risk factors for health-care workers. It recommended that using appropriate assistive equipment can reduce the injuries. If staff is safe, patients are safer. The research team has designed and produced a new transport assistive devices-- biodegradable and air-suspending transfer mattress, which was precisely controlled by gas flow and based on ergonomics. And then apply it to the clinic in order to find whether it's benefit for patients and nursing staff. It is a randomized controlled trial design.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (2)

• Force value

  Spring balance was used to measured the pulling force while transferring patients.(Force value in N)

  Day 1

• perceived exertion

  Perceived exertion was evaluated by using the Borg Scale of 6-20, which the values near 6 and 20 represent low and high physical exertion, respectively.（perceived exertion in scores）

  Day 1

Secondary Outcomes (5)

• respiration rate

  Day 1（before and after transferring）

• blood pressure

  Day 1（before and after transferring）

• heart rate

  Day 1（before and after transferring）

• oxygen saturation

  Day 1（before and after transferring）

• Transfer time

  Day 1

Other Outcomes (2)

• Satisfaction of patient

  Day 1

• Satisfaction of nurse staff

  Day 1

Study Arms (3)

Experimental group

EXPERIMENTAL

Patients in experimental group were transferred by air-suspending mattress.

Device: transferred by air-suspending mattress

control group 1

ACTIVE COMPARATOR

Patients in control group 1 were transferred by slide board.

Device: transferred by slide board

control group 2

ACTIVE COMPARATOR

Patients in control group 2 were transferred by bedsheet.

Device: transferred by bedsheet

Interventions

transferred by air-suspending mattress DEVICE

Put mattress in advance on the bed. When patients need to be transferred from bed to bed, fill the mattress with gas and keep it inflated, then pull the mattress .

Experimental group

transferred by slide board DEVICE

When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.

control group 1

transferred by bedsheet DEVICE

When patients need to be transferred from bed to bed, just lift the bedsheet.

control group 2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Passive patient with transfer requirements, such as CT/ MRI examination , transfer from one department to another etc；Patients or their family signed an informed consent.

You may not qualify if:

• The patients weighted over 150kg and have spine fracture ；age\< 15 years old.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jingfen Jin, Master

  The Second Affiliated Hospital of Medical College of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 28, 2019
• Study Start: March 28, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

CN (1)