Individualized Analgesia in the Intensive Care Unit With a New Pain Assessment Bundle and Protocolized Analgesia Adjustments

NCT07473115 | Not Yet Recruiting

• 1 other identifier: INVISIBLE
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Both severe pain and opioid therapy are associated with negative effects. The experience of pain is common in the intensive care unit, but it is highly individual and difficult to assess, as patients are often unable to communicate. This especially applies to patients who are mechanically ventilated. Behavioral assessment tools can help to identify pain in this population, but do not register overdose of opioid therapy. The AlgiScan® delivers the Pupillary Pain Index (PPI), an objective assessment of nociception level, which has been shown to be useful in small studies with respect to reduction of opioid dose without leading to more pain. New institutional protocols for the assessment of pain include the behavioral pain assessment tool Zurich Observational Pain Assessment (ZOPA) and the PPI. This project aims to evaluate the impact of the new institutional protocols on opioid administration and occurrence of pain compared to a historical cohort by analyzing routinely collected data during mechanical ventilation (Part A). In a second part (Part B), promising biomarkers for detection of pain, subjective ratings by nurses and physicians and an additional behavioral pain scale will be evaluated using an observational study design. After screening and enrolment (day 1/visit 1), characteristics of pain will be assessed on 4 occasions during 2 days (day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5). On visit 2 and 4, biomarkers (alpha-amylase, cortisol) will be sampled.

Conditions

Pain; Pain Management; Critical Illness

Keywords

Pain assessment; Pain management; Critical illness; mechanical ventilation; intensive care unit; Pupillary pain index

Outcome Measures

Primary Outcomes (1)

• Oral morphine equivalent (OME) per day of mechanical ventilation.

  OME is a standardized method to quantify and compare the potency of different opioid drugs by converting their doses into the equivalent amount of oral morphine. Doses are weighted based on the potency of the opioid and then summarized into a final value. Days of mechanical ventilation are weighted based on the hours of mechanical ventilation divided by 24 hours (relevant for days of intubation and extubation).

  Part A: during mechanical ventilation (up to 28 days)

Secondary Outcomes (25)

• Sufentanil dose per day of mechanical ventilation

  Part A: during mechanical ventilation (up to 28 days)

• Opioid dose adjustments - Number of adjustments

  Part A: during mechanical ventilation (up to 28 days)

• Opioid dose adjustments - Relative change during pain assessment

  Part A: during mechanical ventilation (up to 28 days)

• Zurich Observational Pain Assessment (ZOPA)

  Part A: during mechanical ventilation Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5

• Number of rescue analgesics administered per day

  Part A: during mechanical ventilation (up to 28 days)

Other Outcomes (5)

• Delirium

  Part A: during mechanical ventilation (up to 28 days)

• ICU mortality

  Part A: from date of inclusion up to 100 days

• ICU length of stay

  Part A: from date of inclusion up to 100 days

Study Arms (2)

Prospective Cohort

Critically ill and mechanical ventilated patients after implementation of a new institutional protocol for pain assessment and analgesia adjustments

Historic Cohort

Critically ill and mechanical ventilated patients before implementation of a new institutional protocol for pain assessment and analgesia adjustments

Eligibility Criteria

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

Study Population

Mechanically ventilated adult patients in the intensive care unit.

You may qualify if:

• Part A
• Admission to the intensive care unit
• Adults (≥18 years) of all sex and gender
• Mechanical ventilation Part B
• Admission to the intensive care unit
• Adults (≥18 years) of all sex and gender
• mechanical ventilation
• Continuous opioid therapy
• Richmond Agitation Sedation Scale (RASS) ≤ -4
• Presumed duration of mechanical ventilation until the end of observations (until day 3)

You may not qualify if:

• Part A
• None Part B
• Previous enrolment into the current investigation
• Tracheostomy
• Chronic opioid use
• Regional anaesthesia
• Implanted pacemaker device
• Allergy to silicone or ECG-electrodes
• Ophthalmologic disease (e.g. ocular trauma, glaucoma) or past eye surgery
• Fixed pupils
• Known or suspected neurologic disease (including hypoxic encephalopathy)
• Therapy with atropine or topical mydriatics in previous 24 hours or planned
• Therapy with systemic steroids in previous 24 hours or planned
• Therapy with neuromuscular blocking agents in previous 24 hours or planned
• Stomatitis

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pain; Agnosia; Critical Illness

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Rolf Erlebach, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha I David, Professor

CONTACT

+41 43 253 19 02; Sascha.David@usz.ch

Rolf Erlebach, MD

CONTACT

+41 43 253 90 63; Rolf.Erlebach@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)