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

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

Study Contact Backup

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

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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