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Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units

NCT03475238 — Completed, 262 participants, French Society for Intensive Care

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Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study

RegistryNCT03475238, acronym NURSIE
StatusCompleted
Study typeObservational
Enrollment262 (Actual)
SponsorFrench Society for Intensive Care (Other)
ConditionsNursing Caries, Critical Care
InterventionsNursing care (Procedure)
Datesstart 2018-03-29, primary completion 2018-07-15, completion 2019-02-13, first posted 2018-03-23, last updated 2019-02-15
Locations26 sites in Belgium, France, Luxembourg, Switzerland

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-Summary

Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.

Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..)

Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

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+Arms and interventions

ArmTypeInterventionsDescription
Cohort for nursing careProcedure: Nursing carePatients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation
  • Nursing care (Procedure): The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min

+Outcome measures

Primary outcomes

  • Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours) [72 hours]: Determinate incidence of occurrence of at least one SAE (defined below) during the nursing care while the study period (72 hours) The nursing care will be defined as a lateral mobibization and a length of care sup or equal to 10min SAE are considered according to litterature as : * Cardiac arest * Unplanned extubation * Episode of Spo2 riequiring therapeutic intervention * Artificial airway obstruction requiring endotracheal suctionning * Unplanned dislodgements related to lines or catheters drains * Hypotension with therapeutic intervention * Cardiac rhythm disorders with therapeutic intervention * Agitation with therapeutic intervention * Equipment failure or dysfunction * Patient fall * Need for doctor help * Increased intracranial pressure > 20 mmHg * Acute painful crisis

+Eligibility

Sex: All

Inclusion Criteria:

* Health-care affiliated
* Length of ICU stay < 72 h
* Patient with endotracheal tube
* Patient with tracheostomy
* Patient receiving vasoactives drugs (norepinephrine, epinephrine, Dobutamine)
* Patient undergoing no invasive ventilation during 1hour minimum of 24 hours before the selection
* Patient undergoing hight flow oxygen therapy heated and humidified

Exclusion Criteria:

* Patient already included in this study
* Medical contraindication to the bed bath with lateral mobilization
* Withdrawal of life sustaining treatment
* Spinal trauma

+Locations (26)

FacilityCityCountryStatus
Hopital de BruxellesBrusselsBelgium
CHU CharleroiCharleroiBelgium
Hopital Civil Marie CurieCharleroiBelgium
CH Andre MigniotVersailles, AFrance
CHU BesançonBesançonFrance
CHU Ambroise ParéBoulogne-BillancourtFrance
CH Sud FrancilienCorbeil-EssonnesFrance
CH de DaxDaxFrance
CH de la DracénieDraguignanFrance
CHRU LilleLilleFrance
Hopital Jeanne De FlandreLilleFrance
CHU MarseilleMarseilleFrance
CHU NantesNantesFrance
CHU NiceNiceFrance
CHU NimesNîmesFrance
CHR OrléansOrléansFrance
CHU La Pitié SalpétrièreParisFrance
CHU LariboisièreParisFrance
CHU Necker Enfant MaladeParisFrance
Hopital Europeen George PompidouParisFrance
CHU StrasbourgStrasbourgFrance
CHU ToulouseToulouseFrance
CH ValenceValenceFrance
CHI Lucie & Raymond AubracVilleneuve-Saint-GeorgesFrance
Centre Hospitalier Emile MayrischLuxembourgLuxembourg
Hopital de la TourMeyrinSwitzerland

+Investigators

My Notes