Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

NCT05313789 | Unknown

• 1 other identifier: 20180413.2018/04-2
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to examine the usability of ANI in patients who will be treated in intensive care unit.

Conditions

Stress Related Disorder; Pain; Intensive Care Unit Syndrome

Keywords

Analgesia Nociception Index; Intensive Care Unit; Pain Monitoring

Outcome Measures

Primary Outcomes (1)

• Analgesia Nociception Index for pain monitorization

  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

Study Arms (3)

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.

Device: Analgesia Nociception Index (ANI)

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.

Device: Analgesia Nociception Index (ANI)

Intensive Care Patients (Obese)

Intensive care unit patients. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Device: Analgesia Nociception Index (ANI)

Interventions

Analgesia Nociception Index (ANI) DEVICE

Monitorization of Analgesia Nociception Index in Intensive Care Patients

Intensive Care Patients (Cardiovascular); Intensive Care Patients (Internal diseases); Intensive Care Patients (Obese)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients between 18 and 80 years old. White Turkish Population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• İstanbul Yeni Yüzyıl Üniversitesi: lead

Related Publications (6)

• 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.

  PMID: 22360936 BACKGROUND

• 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.

  PMID: 22454275 BACKGROUND

• 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.

  PMID: 25909309 BACKGROUND

• 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.

  PMID: 32076680 BACKGROUND

• 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.

  PMID: 28970658 BACKGROUND

• 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.

  PMID: 26808971 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ali Sefik Koprulu, MD

CONTACT

+905322677226; sefik.koprulu@yeniyuzyil.edu.tr

Ersi Kalfoglou, PhD

CONTACT

+905323500656; ersi.kalfoglu@yeniyuzyil.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 6, 2022
• Study Start: April 11, 2022
• Primary Completion: May 10, 2022
• Study Completion: June 6, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share