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

NCT03475238 | Completed

• 1 other identifier: 2018-A00046-49
• Study Type: observational
• Target: 262
• Locations: 4 countries
• Sites: 26

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.

Conditions

Nursing Caries; Critical Care

Keywords

critical care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cohort for nursing care

Patients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation

Procedure: Nursing care

Interventions

Nursing care PROCEDURE

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

Cohort for nursing care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• French Society for Intensive Care: lead

Study Sites (26)

Hopital de Bruxelles

Brussels, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

Hopital Civil Marie Curie

Charleroi, Belgium

Location

CH Andre Migniot

Versailles, A, France

Location

CHU Besançon

Besançon, France

Location

CHU Ambroise Paré

Boulogne-Billancourt, France

Location

CH Sud Francilien

Corbeil-Essonnes, France

Location

CH de Dax

Dax, France

Location

CH de la Dracénie

Draguignan, France

Location

CHRU Lille

Lille, France

Location

Hopital Jeanne De Flandre

Lille, France

Location

CHU Marseille

Marseille, France

Location

CHU Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

CHU Nimes

Nîmes, France

Location

CHR Orléans

Orléans, France

Location

CHU La Pitié Salpétrière

Paris, France

Location

CHU Lariboisière

Paris, France

Location

CHU Necker Enfant Malade

Paris, France

Location

Hopital Europeen George Pompidou

Paris, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse

Toulouse, France

Location

CH Valence

Valence, France

Location

CHI Lucie & Raymond Aubrac

Villeneuve-Saint-Georges, France

Location

Centre Hospitalier Emile Mayrisch

Luxembourg, Luxembourg

Location

Hopital de la Tour

Meyrin, Switzerland

Location

MeSH Terms

Interventions

Nursing Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mathieu Lloung

  French Intensive Care Society

  STUDY DIRECTOR

• Jean Baptiste Lascarrou, MD

  French Intensive Care Society

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 23, 2018
• Study Start: March 29, 2018
• Primary Completion: July 15, 2018
• Study Completion: February 13, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CH (1); FR (21); BE (3); LU (1)