Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit

NCT ID: NCT02184793

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-04-30

Brief Summary

Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.

The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.

Detailed Description

Maintaining semi-recumbent position (defined by a head of bed inclination between 40° and 50°) is an international guidance to prevent ventilator-associated pneumopathy which is the main nosocomial infection in intensive care unit. However, maintaining such an inclination has been shown to be difficult in day-to-day care.

This could be improved by using an assistance device that would measure inclination of the head of bed in real time and trigger an alarm when the value order is not reached, hence allowing a quick readjustment if necessary.

The investigators want to evaluate en electronic monitoring device (EMD) that is removable and adjustable to all beds, which would allow a whole intensive care unit to be fully equipped at low cost.

Hypothesis : using an EMD could improve the proportion of time spent per day in semi-recumbent position (defined by a head of bed inclination between 40° and 50°) in mechanically-ventilated patients.

Primary objective : to evaluate the impact of an EMD with alarm on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.

Secondary objectives :

• to evaluate the impact of the EMD on the head of bed inclination overall mean
• to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination superior to 30°
• to evaluate the impact of the EMD on the proportion of time spent per day with a head of bed inclination between 30° and 45°
• to study factors associated to a head of bed inclination inferior to 30° for more than 12hrs per 24hrs

Conditions

Mechanically-ventilated Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

EMD (Inclinomax) then usual care

EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h.

Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h.

Group Type: OTHER

EMD (Inclinomax)

Intervention Type: DEVICE

EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on

usual care then EMD (Inclinomax)

Usual care : recording the head of bed inclination degree with masked digital display and alarm off for 24h.

EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on for 24h.

Group Type: OTHER

EMD (Inclinomax)

Intervention Type: DEVICE

EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on

Interventions

EMD (Inclinomax)

EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on

Intervention Type: DEVICE

Other Intervention Names

EMD (electronic monitoring device)

Eligibility Criteria

Inclusion Criteria

• patient with invasive mechanical ventilation
• expected mechanical ventilation duration for more than 48h after inclusion
• signature of an informed consent by a relative
• patient affiliated to a social security scheme (beneficiary or assignee)

Exclusion Criteria

• age<18 years old
• mechanical ventilation with tracheotomy
• contraindication to semirecumbent position (e.g., spinal cord injury, important sacral bedsore, counterpulsation balloon, femoral cannulation for extracorporeal circulation) or expected indication to another position within the following 48 h after inclusion (e.g., ventral decubitus for hypoxemia pulmonary pathology)
• SAPS II score > 65 at the admission (moribund patients)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lila Bouadma, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat Claude Bernard

Paris, , France

Countries

France

Other Identifiers

P080407

Identifier Type: -

Identifier Source: org_study_id