NCT00847665

Brief Summary

The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the incidence of grade \> II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥ 24h that use alternating-pressure air mattresses (APAMs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 17, 2013

Completed
Last Updated

April 17, 2013

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

February 18, 2009

Results QC Date

June 28, 2012

Last Update Submit

March 9, 2013

Conditions

Pressure Ulcers

Keywords

Pressure ulcersRepositioningPreventionMechanical VentilationCritical care

Outcome Measures

Primary Outcomes (1)

  • Incidence of Pressure Ulcer (PU) Grade ≥ II

    Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer

    Intensive Care Unit (ICU) length of stay (days)

Secondary Outcomes (3)

  • ICU Mortality

    ICU length of stay (an average of 28 days)

  • Workload of Nurses

    icu length of stay

  • Length of Mechanical Ventilation (MV)

    ICU length of stay

Study Arms (2)

Turning every 4 hours

ACTIVE COMPARATOR

The four-hours repositioning group patients were turned every four hours following the next sequence: left side, back with a 30º elevation of the head end and the foot end of the bed, right side using the 30º tilt, back.

Other: repositioning

Turning every 2 hours

EXPERIMENTAL

The two-hours repositioning group patients, were turned every two hours following the next sequence: left side, back with a 30º elevation of the head end and the foot end of the bed, right side using the 30º tilt, back.

Other: repositioning

Interventions

repositioningOTHER

Turning every 4 or 2 hours

Turning every 2 hoursTurning every 4 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the medical-surgical ICU, requiring more than 24 hours of mechanical ventilation.
  • Patients on alternating-pressure air mattresses.
  • Patients or their legal representative able to provide written informed consent to participate in the study
  • Patients whose weight are within the limits accepted by the mattresses (45-140 Kg)
  • Over 18 years

You may not qualify if:

  • Patients with pressure ulcer at ICU admission.
  • Pregnant patients
  • Patients in which informed consent is not obtained in the first 48 hours of mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Related Publications (3)

  • Vanderwee K, Grypdonck MH, De Bacquer D, Defloor T. Effectiveness of turning with unequal time intervals on the incidence of pressure ulcer lesions. J Adv Nurs. 2007 Jan;57(1):59-68. doi: 10.1111/j.1365-2648.2006.04060.x.

    PMID: 17184374BACKGROUND

  • Defloor T, De Bacquer D, Grypdonck MH. The effect of various combinations of turning and pressure reducing devices on the incidence of pressure ulcers. Int J Nurs Stud. 2005 Jan;42(1):37-46. doi: 10.1016/j.ijnurstu.2004.05.013.

    PMID: 15582638BACKGROUND

  • Krapfl LA, Gray M. Does regular repositioning prevent pressure ulcers? J Wound Ostomy Continence Nurs. 2008 Nov-Dec;35(6):571-7. doi: 10.1097/01.WON.0000341469.33567.61.

    PMID: 19018196BACKGROUND

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Francisco Manzano
Organization
University Hospital Virgen de las Nieves
fmanzano@mailpersonal.com
34958020125

Study Officials

  • Francisco Manzano, MD,PhD

    University Hospital Virgen de las Nieves

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 17, 2013

Results First Posted

April 17, 2013

Record last verified: 2013-03

Locations

ES(1)