Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

Sponsor
İstanbul Yeni Yüzyıl Üniversitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05313789
Collaborator
(none)
180
1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Analgesia Nociception Index (ANI)

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 Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Analgesia Nociception Index for Pain Monitoring in Intensive Care Units
Anticipated Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
May 10, 2022
Anticipated Study Completion Date :
Jun 6, 2022

Arms and Interventions

Arm 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.

Device: Analgesia Nociception Index (ANI)
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.

Device: Analgesia Nociception Index (ANI)
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.

Device: Analgesia Nociception Index (ANI)
Monitorization of Analgesia Nociception Index in Intensive Care Patients

Outcome Measures

Primary Outcome Measures

  1. Analgesia Nociception Index for pain monitorization [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • İstanbul Yeni Yüzyıl Üniversitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Sefik Koprulu, MD, Ass. Prof., Ass. Prof., İstanbul Yeni Yüzyıl Üniversitesi
ClinicalTrials.gov Identifier:
NCT05313789
Other Study ID Numbers:
  • 20180413.2018/04-2
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali Sefik Koprulu, MD, Ass. Prof., Ass. Prof., İstanbul Yeni Yüzyıl Üniversitesi

Study Results

No Results Posted as of Apr 6, 2022