Clinical trial NCT03475238: Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units
Official title: Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nursing Caries
Critical Care
Keywords: critical care
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 262
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Each participating unit will include all consecutive patients staying in the ICU.

Each day a screening of the patients will be released between 8 and 10 am.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hopital de Bruxelles
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Charleroi
country: Belgium
facility: Hopital Civil Marie Curie
city: Versailles
country: France
facility: CH Andre Migniot
state: A
city: Besançon
country: France
facility: CHU Besançon
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Dax
country: France
facility: CH de Dax
city: Draguignan
country: France
facility: CH de la Dracénie
city: Lille
country: France
facility: CHRU Lille
city: Lille
country: France
facility: Hopital Jeanne De Flandre
city: Marseille
country: France
facility: CHU Marseille
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nimes
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: CHU La Pitié Salpétrière
city: Paris
country: France
facility: CHU Lariboisière
city: Paris
country: France
facility: CHU Necker Enfant Malade
city: Paris
country: France
facility: Hopital Europeen George Pompidou
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Valence
country: France
facility: CH Valence
city: Villeneuve-Saint-Georges
country: France
facility: CHI Lucie & Raymond Aubrac
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier Emile Mayrisch
city: Meyrin
country: Switzerland
facility: Hopital de la Tour
Study officials:
affiliation: French Intensive Care Society
name: Mathieu Lloung
role: STUDY_DIRECTOR
affiliation: French Intensive Care Society
name: Jean Baptiste Lascarrou, MD
role: STUDY_CHAIR
References: