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

NCT ID: NCT03475238

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-29

Study Completion Date

2019-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nursing Caries Critical Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort for nursing care

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

Nursing care

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nursing care

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

French Society for Intensive Care

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mathieu Lloung

Role: STUDY_DIRECTOR

French Intensive Care Society

Jean Baptiste Lascarrou, MD

Role: STUDY_CHAIR

French Intensive Care Society

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital de Bruxelles

Brussels, , Belgium

Site Status

CHU Charleroi

Charleroi, , Belgium

Site Status

Hopital Civil Marie Curie

Charleroi, , Belgium

Site Status

CH Andre Migniot

Versailles, A, France

Site Status

CHU Besançon

Besançon, , France

Site Status

CHU Ambroise Paré

Boulogne-Billancourt, , France

Site Status

CH Sud Francilien

Corbeil-Essonnes, , France

Site Status

CH de Dax

Dax, , France

Site Status

CH de la Dracénie

Draguignan, , France

Site Status

CHRU Lille

Lille, , France

Site Status

Hopital Jeanne De Flandre

Lille, , France

Site Status

CHU Marseille

Marseille, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Nice

Nice, , France

Site Status

CHU Nimes

Nîmes, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

CHU La Pitié Salpétrière

Paris, , France

Site Status

CHU Lariboisière

Paris, , France

Site Status

CHU Necker Enfant Malade

Paris, , France

Site Status

Hopital Europeen George Pompidou

Paris, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CH Valence

Valence, , France

Site Status

CHI Lucie & Raymond Aubrac

Villeneuve-Saint-Georges, , France

Site Status

Centre Hospitalier Emile Mayrisch

Luxembourg, , Luxembourg

Site Status

Hopital de la Tour

Meyrin, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium France Luxembourg Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A00046-49

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.