Impact of a Nurse Implemented Sedation and Analgesia Algorithm in Surgical Intensive Care Unit

NCT ID: NCT03186521

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-12-31

Brief Summary

To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.

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.

Conditions

Sedation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Extubation <48 hours after inclusion
• Deaths <48 hours after inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique POTTIER, MD

Role: PRINCIPAL_INVESTIGATOR

department of anesthesia and intensive care, caen university hospital

Locations

POTTIER

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Véronique POTTIER, MD

Role: CONTACT

pottier-v@chu-caen.fr

33231064736

Facility Contacts

Véronique POTTIER, MD

Role: primary

pottier-v@chu-caen.fr

+33231064736

Other Identifiers

15-147

Identifier Type: -

Identifier Source: org_study_id