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

Completed

• Conditions: Nursing Caries; Critical Care
• Interventions: Procedure: Nursing care

• Registration Number: NCT03475238
• Lead Sponsor: French Society for Intensive Care

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Study Start: 2018-03-29
• Primary Completion: 2018-07-15
• Status Verified: 2019-02
• Study Completion: 2019-02-13
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort for nursing care	Nursing care	Patients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (26)

CHU Charleroi; 🇧🇪 Charleroi, Belgium

Hopital Civil Marie Curie; 🇧🇪 Charleroi, Belgium

CH Andre Migniot; 🇫🇷 Versailles, A, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

CH Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

CH de la Dracénie; 🇫🇷 Draguignan, France

CH de Dax; 🇫🇷 Dax, 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

CH Valence; 🇫🇷 Valence, France

CHI Lucie & Raymond Aubrac; 🇫🇷 Villeneuve-Saint-Georges, France

CHU Toulouse; 🇫🇷 Toulouse, France

Hopital de la Tour; 🇨🇭 Meyrin, Switzerland

Centre Hospitalier Emile Mayrisch; 🇱🇺 Luxembourg, Luxembourg

Hopital de Bruxelles; 🇧🇪 Bruxelles, Belgium