Dr Signouret Thomas

Alarms Externalisation

Patients Vital prognosis committed Multiorgan failure

Cares : Invasives, painfull, 24 h/24 Life support equipment: ventilator, dyalisis,

infusion pumps Monitoring: 24 h/24

Caregivers Monitoring device

Intensive care unit

Currently average noise: 60 → 70 dB Alarms : 70 → 80 dB !!! Staff conversations: 59 → 90 dB

Bush-Vishniac J acoust soc Am 2005 10 à 25 % of alarms do induce a therapeutic modification

Lawless ST Crit Care Med 1994 Patients:

Disturbance Tachycardia, hypertension Pituitary and adrenal gland stimulation

Xie Crit care 2009 Nurses: Concentration, stress, Phenomen of alarm fatigue

Morrison Crit Care Med 2003Chambrin MC crit care 2001

Noise: World Health Organisation guidelines: 35→40 dB

Sleep disturbance:

Slower healing

Cognitive function

Décrease immune response

ICU delirium : 20 →80 % ↗ lenght of stay

↗ morbi-mortalityEly EW JAMA 2004

Noise is one of many factors of sleep disturbance: 17→ 56 %

Xie Crit care 2009

Link between noise and sleep disturbance ?

1. Remove the cardiacs monitor alarms from the

room to the centrale station

2. Close the patient door’s room

3. Pb: What about the others devices Alarm’s ?

4. Need a translation of all the alarm in the same

language (HL7): Capsultech®

5. Need to bring and allocate the alarm to the

caregiver: Connexall®

Historic

Decrease the noise due to the alarms in the patient room.

Allow the door closing: Decrease the noise from the nursing station

- 4 dB: Lawson Am J Crit Care 2010 Overpressure level respected in the unit

Aspergillose prevention

R113: Référentiel struct Vdef 2011

Alarms send to caregivers Tracability

Aims of the Externalisation alarms

Cardiac arrest(vital priority) : Vital emmergency who need an immediat respons of all the caregivers( nurses and doctor) of intensive care unit

Critical (high priority ) : Urgent situation who require an immediat response of caregivers

Grave (medium priority) : Imminent risk who requires a rapid response of caregivers

Message (low priority) : Attention of medical staff is require

European standard medical devices.EN 475:1995

Définition of gravity level

Changement poche Réinjection Alerte changement poche Changement poche MessagePression transmembranaire élevée Alerte PTM élevée PTM ↗ GraveGain excessif poids patient Arrêt pompe sang ↕ pompe sang Critique

Mapping alarms

Arrêt pompe (= Occlusion) Occlusion Perfusion ↕ PSE GraveRelais seringue imminent Relais seringue imminent relais PSE imminent MessageBulle d’air (Pompe) Bulle d'air perfusion bulle d'air Grave

Fibrillation V Fibrillation ventriculaire Fibr V VitaleTachycardie V Tachycardie Ventriculaire TV CritiqueCouplet Couplet Couplet Message

Cause/message machine Affi chage Connexall affi chage simplifié Criticité

Delai total(sec)

Delai Connexall

(sec)

Duree apres ackw

Nombre de repetitions

Interval entre chaque

repetitions (sec)

Duree apres ackw

Nombre de repetitions

Interval entre

chaque (sec)

Duree apres ackw

Nombre de

repetitions

Interval (sec)

Vitale 5 2 90 9999 15 0 0 1 0 0 1

Critique 5 2 90 2 20 90 2 20 60 0 40

Grave 10 7 90 2 30 90 2 30

Message 15 12 9999 0 20 0 0 15 0 0 15

Specification pour chaque alarme

Primaire Secondaire Backup

Workflow

The Daily Job of the Nurse

Hardware connectivity

Check devices connexion

Specific connection by DIM Capsultech® on device RS232 outlet

Connection IT wires on DATACAPTOR®module for sending the information on the network

Connexall central station: Assignement of each patient on an iPoD which is

dedicated to a nurse

Sélect and Assign the patients

303 302301305304

R2.2 R2.1

Assignment

Connexall Central stationMain Screen

Alarms on mobile Device

Arrêt cardiaque box 1

Acknowledgment

Golive on a five beds unit after a training of all nurses of the unit

Connection of all devices Good expression of the sonor Alarms with right

tonality, gravity and workflow Visual alarms: Good rendering Doors closed recently We left the sound in the box due to an IT server

issue

Currently

Log out the devices from the datacaptor

4 or 5 network Drager Capsultech Connexall Hopital européen Marseille Apple

Regulated Medical Devices Class II FDA

Alarm Externalisation Risk

A visual indicator of log out on connexall central station

An automatic detection of IT server issue by heart bit then

an alarm message with a workflow to: Drager IT engineer

Biomed

Doctor

Chief nurse

A new device who avoid apple network

Evaluation the quality of caregivers réaction

What we expected ? Sécurity

Transitory (2min) Inhibition of the transmission of all alarm on the Connexall system when the Nurse active “a nursing function”

Showing the waves in live in case of alarm: Link patient watch

Sending vocal message with: 1st : the sound characteristic of level of gravity 2nd : the number of room 3rd : the message of alarm

And Also…: Dévellopment

Link on patient watch

Evaluation

1. Safety2. Efficacy3. Perception

Safety

Description of differents alarm :

Number of alarm / hour and /12 h Number by device Number by nurse Number by gravity

Delay between alarm and acknowledgment

Delay between alarm and resolution

Efficacy

Average intensity noise during day and night : In the room In the nurse station

Number of Peak level > 80 dB/ h during day and night :

In the room In the nurse station

Perception

Patient questionnaire : Sleep quality : Richards Campbell Sleep Questionnaire Noise discomfort

Care givers quetionnaire : Noise discomfort Satisfaction

Primary purpose: réduction of 10 dB by currently average noise level 60 +/- 10 dB

We need 16 patients in each stategies Power: 80 % alpha risk : 5 %

A prospective open interventionnel study évaluate a reducing stratégy of noise by

an alarm notification system

Extended the externalisation of the alarm to other medical Device ECMO, Bed, Labs, etc…

Extended the externalisation of the alarm to other medical specialties Anesthesia : An anesthesiologist works on several

OR Cardiology

Special device to show the alarm: Samsung gear, Google Glasses

Middle and Long terms Plan

Thank you for you attention

Functionnal Basics of Third-Party Alarm Notification Systems

B Moorman Biomed Instrumentation and Technology 2011