Nursing CariesNURSIENCT03475238
Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units
An observational study of Nursing Caries and Critical Care, run by French Society for Intensive Care at 26 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nursing Caries, Critical Care
- What is being tested?
- Nursing care
- Type of treatment
- Surgery or procedure
- How many people
- 262 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 29 Mar 2018to 13 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient already included in this study
- Medical contraindication to the bed bath with lateral mobilization
- Withdrawal of life sustaining treatment
- Spinal trauma
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
France21 sites
CHU Besançon
Besançon
CHU Ambroise Paré
Boulogne-Billancourt
CH Sud Francilien
Corbeil-Essonnes
CH de Dax
Dax
CH de la Dracénie
Draguignan
CHRU Lille
Lille
Hopital Jeanne De Flandre
Lille
CHU Marseille
Marseille
CHU Nantes
Nantes
CHU Nice
Nice
CHU Nimes
Nîmes
CHR Orléans
Orléans
CHU La Pitié Salpétrière
Paris
CHU Lariboisière
Paris
CHU Necker Enfant Malade
Paris
Hopital Europeen George Pompidou
Paris
CHU Strasbourg
Strasbourg
CHU Toulouse
Toulouse
CH Valence
Valence
CH Andre Migniot
Versailles, A
CHI Lucie & Raymond Aubrac
Villeneuve-Saint-Georges
Belgium3 sites
Hopital de Bruxelles
Brussels
CHU Charleroi
Charleroi
Hopital Civil Marie Curie
Charleroi
About this study
Official title: 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.
- Conditions
- Nursing Caries, Critical Care
- Being tested
- Nursing care
- Keywords
- critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing careProcedure or surgery
The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min
| Study group | Role | What they receive |
|---|---|---|
| Cohort for nursing care | Patients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation Receives: Procedure: Nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start29 Mar 2018
- Primary completion15 Jul 2018
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Lloung, Study director, French Intensive Care SocietyJean Baptiste Lascarrou, MD, Study chair, French Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475238
- Sponsor's protocol ID
- 2018-A00046-49
- Acronym
- NURSIE
- Status last verified
- Feb 2019
- First submitted
- 11 Mar 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Research on the Occurrence of Serious Adverse Events in Intensive Care Unit During Bed Bath and Nursing Care. NURSIE Study
- ClinicalTrials.gov ID
- NCT03475238
- Acronym / sponsor ID
- NURSIE / 2018-A00046-49
- Conditions
- Nursing Caries, Critical Care
- Keywords
- critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort for nursing care | – | Procedure: Nursing carePatients in ICU under oxygen and/or mechanical ventilation and/or vasoactive drugs and/or non-invasive ventilation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Health-care affiliated
- Length of ICU stay < 72 h
- Patient with endotracheal tube
- Patient with tracheostomy
- Patient receiving vasoactives drugs (norepinephrine, epinephrine, Dobutamine)
Key exclusion criteria (4 listed)
- Patient already included in this study
- Medical contraindication to the bed bath with lateral mobilization
- Withdrawal of life sustaining treatment
- Spinal trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing careThe nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min | Procedure or surgery | Cohort for nursing care |
Primary outcome
Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Nursing Caries
Not yet recruitingPhase 4
Oral Hygiene Assistance Training Program
Elderly, Periodontal Disease
Not yet recruiting
Virtual Escape Room Game About Medical Device in Nurses
Nursing Caries, Pressure Injuries
Recruiting
Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control
Periodontitis, Gingivitis
Not yet recruiting
Flipped Learning Model on the Stoma Care
Stoma Colostomy, Nursing Caries
Not yet recruiting
Flipped Learning Model on Nursing Students' Thorax and Heart Examination
Nursing Students, Nursing Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Lloung study director
French Intensive Care Society
Jean Baptiste Lascarrou, MD study chair
French Intensive Care Society
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nursing Caries and Critical Care, run by French Society for Intensive Care at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Belgium, Luxembourg, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of occurrence of at least one serious avderse event (SAE) (defined below) during the nursing care while the study period (72 hours) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.