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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Nursing Caries
• Intervention / Treatment: Procedure: Nursing care

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Hopital de Bruxelles
  • Charleroi, Belgium
    • CHU Charleroi
  • Charleroi, Belgium
    • Hôpital Civil Marie Curie
• France
  • Besançon, France
    • CHU Besançon
  • Boulogne-Billancourt, France
    • CHU Ambroise Pare
  • Corbeil-Essonnes, France
    • Ch Sud Francilien
  • Dax, France
    • CH de Dax
  • Draguignan, France
    • CH de la Dracénie
  • Lille, France
    • CHRU Lille
  • Lille, France
    • Hôpital Jeanne de Flandre
  • Marseille, France
    • CHU Marseille
  • Nantes, France
    • CHU Nantes
  • Nice, France
    • CHU Nice
  • Nîmes, France
    • CHU Nîmes
  • Orléans, France
    • CHR Orléans
  • Paris, France
    • Chu Lariboisiere
  • Paris, France
    • Chu La Pitie Salpetriere
  • Paris, France
    • Hôpital Européen George Pompidou
  • Paris, France
    • CHU Necker Enfant Malade
  • Strasbourg, France
    • CHU Strasbourg
  • Toulouse, France
    • CHU Toulouse
  • Valence, France
    • CH Valence
  • Villeneuve-Saint-Georges, France
    • CHI Lucie & Raymond Aubrac
  • A
    • Versailles, A, France
      • CH Andre Migniot
• Luxembourg
  • Luxembourg, Luxembourg
    • Centre Hospitalier Emile Mayrisch
• Switzerland
  • Meyrin, Switzerland
    • Hôpital de la Tour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: French Society for Intensive Care
• Investigators: Study Director: Mathieu Lloung, French Intensive Care Society; Study Chair: Jean Baptiste Lascarrou, MD, French Intensive Care Society

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: critical care
• Other Study ID Numbers: 2018-A00046-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No