Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

• Conditions: Pain; Stress Related Disorder; Intensive Care Unit Syndrome
• Interventions: Device: Analgesia Nociception Index (ANI)

• Registration Number: NCT05313789
• Lead Sponsor: İstanbul Yeni Yüzyıl Üniversitesi

Brief Summary

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

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Study Start: 2022-04-11
• Primary Completion: 2022-05-10
• Study Completion: 2022-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive Care Patients (Cardiovascular)	Analgesia Nociception Index (ANI)	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.
Intensive Care Patients (Internal diseases)	Analgesia Nociception Index (ANI)	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.
Intensive Care Patients (Obese)	Analgesia Nociception Index (ANI)	Intensive care unit patients. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Primary Outcome Measures

Name	Time	Method
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.