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

Critical Care Clinical Trial

— NURSIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475238
• Other study ID #: 2018-A00046-49
• Status: Completed
• Start date: March 29, 2018
• Est. completion date: February 13, 2019

Study information

• Verified date: February 2019
• Source: French Society for Intensive Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: February 13, 2019
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Nursing Caries

Intervention

Procedure:
• Nursing care
The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min

Locations

Country	Name	City	State
Belgium	Hopital de Bruxelles	Bruxelles
Belgium	CHU Charleroi	Charleroi
Belgium	Hopital Civil Marie Curie	Charleroi
France	CHU Besançon	Besançon
France	CHU Ambroise Paré	Boulogne-Billancourt
France	CH Sud Francilien	Corbeil-Essonnes
France	CH de Dax	Dax
France	CH de la Dracénie	Draguignan
France	CHRU Lille	Lille
France	Hopital Jeanne De Flandre	Lille
France	CHU Marseille	Marseille
France	CHU Nantes	Nantes
France	CHU Nice	Nice
France	CHU Nimes	Nîmes
France	CHR Orléans	Orléans
France	CHU La Pitié Salpétrière	Paris
France	CHU Lariboisière	Paris
France	CHU Necker Enfant Malade	Paris
France	Hopital Europeen George Pompidou	Paris
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CH Valence	Valence
France	CH Andre Migniot	Versailles	A
France	CHI Lucie & Raymond Aubrac	Villeneuve-Saint-Georges
Luxembourg	Centre Hospitalier Emile Mayrisch	Luxembourg
Switzerland	Hopital de la Tour	Meyrin

Sponsors (1)

Lead Sponsor	Collaborator
French Society for Intensive Care

Countries where clinical trial is conducted

Belgium,  France,  Luxembourg,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (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	72 hours