- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313789
Analgesia Nociception Index for Pain Monitoring in Intensive Care Units
March 29, 2022 updated by: Ali Sefik Koprulu, MD, Ass. Prof., İstanbul Yeni Yüzyıl Üniversitesi
The aim of this study is to examine the usability of ANI in patients who will be treated in intensive care unit.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
The aim of this study is to examine the usability of Analgesia Nociception Index in patients who will be treated in intensive care unit ( a- Cardiovascular b- surgical c- internal diseases), mechanically ventilated and lacking communication.
The investigators will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali Sefik Koprulu, MD
- Phone Number: +905322677226
- Email: sefik.koprulu@yeniyuzyil.edu.tr
Study Contact Backup
- Name: Ersi Kalfoglou, PhD
- Phone Number: +905323500656
- Email: ersi.kalfoglu@yeniyuzyil.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Intensive care patients between 18 and 80 years old.
White Turkish Population.
Description
Inclusion Criteria:
- Intensive Care Cardiovascular Patients Group 1 - Patients aged from 18 to 80 years, scheduled for elective isolated coronary bypass graft (CABG) for 2-4 vessel disease, without any perioperative complications, and who were postoperatively monitored via the analgesia nociception index in the cardiovascular intensive care will be included.
- Intensive Care Internal Diseases Group 2 - Patients aged from 18 to 80 years, intubated or tracheostomized, In mechanical ventilation with Pressure-Controlled Ventilation mode, under perfusion neuromuscular blocker, Normothermic, non-cooperative and/or sedated and neuromuscular blocker
- Intensive Care Patients (Obese) Group 3 - Post Bariatric surgery, over 40 BMI
Exclusion Criteria:
- Intensive Care Cardiovascular Patients Group 1 Patients who required emergency surgery, had significant preoperative chronic pain, had autonomic nervous system anomalies and patients with rhythm will be excluded from the study.
- Intensive Care Internal Diseases Group 2 Ramsey sedation scale under 5, cooperative, with spontaneous breathing effort and extremity movement, non sinusal cardiac rhythm
- Intensive Care Patients (Obese) Group 3 - patients under 40 BMI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intensive Care Patients (Cardiovascular)
Intensive care unit patients, mechanically ventilated and lacking communication.
Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.
|
Monitorization of Analgesia Nociception Index in Intensive Care Patients
|
Intensive Care Patients (Internal diseases)
Intensive care unit patients, both mechanically ventilated and lacking communication and mechanically ventilated and conscious.
Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.
|
Monitorization of Analgesia Nociception Index in Intensive Care Patients
|
Intensive Care Patients (Obese)
Intensive care unit patients.
Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.
|
Monitorization of Analgesia Nociception Index in Intensive Care Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia Nociception Index for pain monitorization
Time Frame: 3 Months
|
The duration between two R waves within heart rate variations (filtering the variations in respiratory cycles).
A numeric measure of parasympathetic tonus will be obtained.
This variation is between (pΣ) 0 and 100.
|
3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.
- Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.
- Dias Dde S, Resende MV, Diniz Gdo C. Patient stress in intensive care: comparison between a coronary care unit and a general postoperative unit. Rev Bras Ter Intensiva. 2015 Jan-Mar;27(1):18-25. doi: 10.5935/0103-507X.20150005. Epub 2015 Mar 1.
- Soral M, Altun GT, Dincer PC, Arslantas MK, Aykac Z. Effectiveness of the Analgesia Nociception Index Monitoring in Patients Who Undergo Colonoscopy with Sedo-Analgesia. Turk J Anaesthesiol Reanim. 2020 Feb;48(1):50-57. doi: 10.5152/TJAR.2019.45077. Epub 2019 Sep 24.
- Jendoubi A, Abbes A, Ghedira S, Houissa M. Pain Measurement in Mechanically Ventilated Patients with Traumatic Brain Injury: Behavioral Pain Tools Versus Analgesia Nociception Index. Indian J Crit Care Med. 2017 Sep;21(9):585-588. doi: 10.4103/ijccm.IJCCM_419_16.
- Broucqsault-Dedrie C, De Jonckheere J, Jeanne M, Nseir S. Measurement of Heart Rate Variability to Assess Pain in Sedated Critically Ill Patients: A Prospective Observational Study. PLoS One. 2016 Jan 25;11(1):e0147720. doi: 10.1371/journal.pone.0147720. eCollection 2016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 11, 2022
Primary Completion (ANTICIPATED)
May 10, 2022
Study Completion (ANTICIPATED)
June 6, 2022
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
March 29, 2022
First Posted (ACTUAL)
April 6, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 6, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20180413.2018/04-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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