- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03186521
Impact of a Nurse Implemented Sedation and Analgesia Algorithm in Surgical Intensive Care Unit (ALGOSEDA)
Impact of a Nurse Implemented Sedation and Analgesia Algorithm on Complications of Critical Illness and Outcome of Surgical Intensive Care Patients
Study Overview
Status
Conditions
Detailed Description
Outcome Measures : The primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. The goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. For this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the ICU stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). The primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in ICU and in hospital, mortality and other complications.
Methods: The two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. Quantitative comparisons of data following a normal distribution will be done using a Student's t test. Otherwise quantitative data will be compared using a Mann-Whitney test or Wilcoxon. The comparison of qualitative data will be done using a Fisher exact test. To increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Caen, France, 14033
- Recruiting
- POTTIER
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Contact:
- Véronique POTTIER, MD
- Phone Number: +33231064736
- Email: pottier-v@chu-caen.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.
- Age greater than 18 years.
Exclusion Criteria:
- Patient under guardianship or <18.
- Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy
- Neuromuscular blocking agents at the time of inclusion
Secondary Exclusion criteria:
- Extubation <48 hours after inclusion
- Deaths <48 hours after inclusion
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of mechanical ventilation
Time Frame: baseline
|
Duration between endotracheale intubation and extubation
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Véronique POTTIER, MD, department of anesthesia and intensive care, caen university hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 15-147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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