Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface (FlessCare)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01976897
First received: October 30, 2013
Last updated: August 4, 2014
Last verified: May 2014
  Purpose

The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).


Condition Intervention
Adult, Hospitalized
Other: Knee flexion measurement 1
Other: Knee flexion measurement 2
Other: Heel - interface pressure measurements

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks). [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Maximum pressure on the heel area (Ptal) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean pressure over the entire heel area (P mean) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Measurement of the contact surface of the heel zone (Stal) having a pressure greater than 60 mmHg [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Concordance for skin marks for knee flexion angles between 2 operators for 30 knees. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    relaxed, decubitus dorsal position

  • Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Relaxed decubitus dorsal position


Other Outcome Measures:
  • Age [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Sex [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Weight (kg) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Height (cm) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Braden risk scale [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: March 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The study population

Only one group is included. See inclusion/exclusion criteria.

Intervention: Knee flexion measurement 1

Intervention: Knee flexion measurement 2

Intervention: Heel - interface pressure measurements

Other: Knee flexion measurement 1
The angle of knee flexion during resting, supine position is measured by a first person.
Other: Knee flexion measurement 2
The angle of knee flexion during resting, supine position is measured by a second person.
Other: Heel - interface pressure measurements

The pressure analysis system used is the X Sensor X3 model (Xsensor Technology Corporation, Calgary, Canada). The sensor mat is made up of transducer cells, each measuring 1.6 cm^2. The digital signal is transmitted to a PC via a USB port at a sampling frequency of 10Hz. Before each measurement, the sensor mat is calibrated from 10 to 220 mm Hg, according to the manufacturer's recommendations.

The sheet of pressure sensors is disposed on the dedicated bed. The patient is then asked to take his/her usual position in the supine position and a latency of 5 minutes is observed. The recording time pressure is then performed for 90 seconds in the optical observing time to adapt to changes in media.


Detailed Description:

The secondary objectives of this study are:

A. To evaluate the relationship between the angle of flexion of the knee in DDPD and the average pressure throughout the heel area (Pmean).

B. To evaluate the relationship between the angle of flexion of the knee in DDPD and the contact surface of the heel area (Stal) where the pressure is greater than 60 mm Hg.

C. To evaluate the inter-operator concordance for the knee flexion angle measurement in DDPD via photos.

D. To evaluate the inter-operator concordance for skin marks used to measure knee flexion angles in DDPD via photos (only one knee for 30 patients).

E. To evaluate the inta-operator concordance (measures on 2 consecutive days) for skin marks used to measure knee flexion angles in DDPD via photos (for 30 patients).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.

Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is in a stable medical state (no complications within the past 10 days)

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient has had medical complications within the ten days preceding study inclusion
  • The patient has a bed-sore or bandages on his/her heels
  • The patient has had a lower-limb amputation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976897

Locations
France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Emilie Viollet, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01976897     History of Changes
Other Study ID Numbers: LOCAL/2013/EVFN-01, 2013-A01063-42
Study First Received: October 30, 2013
Last Updated: August 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
heel - mattress pressure interface
flexion
knee angular position

ClinicalTrials.gov processed this record on August 27, 2014