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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sufentanil dose per day of mechanical ventilation | average dose [mcg/min] | Part A: during mechanical ventilation (up to 28 days) |
| Opioid dose adjustments - Number of adjustments | Number of dose adjustments [/hour] and direction |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Positive delirium assessment based on ICDSC and/or CAM-ICU The Intensive Care Delirium Screening Checklist (ICDSC) is an 8-item tool used to assess and detect delirium in critically ill patients. A score of 4 or more suggests the presence of delirium. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a bedside tool used by clinicians to diagnose delirium in critically ill patients. It assesses 4 dimensions. The output is a qualitative result: "delirium absent" or "delirium present". |
Inclusion Criteria:
Part A
Exclusion Criteria:
Part A
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Mechanically ventilated adult patients in the intensive care unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Rolf Erlebach, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
Ethical restrictions
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| Part A: during mechanical ventilation (up to 28 days) |
| Opioid dose adjustments - Relative change during pain assessment | Relative change of dose 45min after vs. 15min before ZOPA/PPI | Part A: during mechanical ventilation (up to 28 days) |
| Zurich Observational Pain Assessment (ZOPA) | The Zurich Observational Pain Assessment (ZOPA) is a validated behavioural pain assessment tool routinely used in the intensive care unit. The ZOPA includes 13 items in 4 categories. Each item is rated on a binary scale (yes or no), resulting in a minimum of zero and a maximum of 13 points. One or more positive item (meaning the item is rated with "yes") is interpreted as probable existing pain. | 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 | Bolus administration of opioids | Part A: during mechanical ventilation (up to 28 days) |
| Occurrence of adverse effects of pain per day of mechanical ventilation |
| Part A: during mechanical ventilation (up to 28 days) |
| Number of sedatives used per day of mechanical ventilation | Average number of sedatives used in the intensive care unit (e.g. Propofol, Clonidine, Dexmedetomidine, Ketamine, Sevoflurane and Midazolam) | Part A: during mechanical ventilation (up to 28 days) |
| Richmond Agitation Sedation Scale (RASS) < -3 | Duration of Richmond Agitation Sedation Scale (RASS) < -3 per total ventilation days. The RASS is a validated 10-point scale with a range from -5 (unarousable) to +4 (combative), with 0 being "alert and calm". | Part A: during mechanical ventilation (up to 28 days) |
| Time to extubation | Time to extubation from stop of analgosedation [hours] | Part A: From time of stop of analgosedation (during mechanical ventilation, up to 28 days) until extubation (up to 7 days). Events such as death or referrals while being intubated will be censored. |
| Opioid prescription at ICU discharge | - Opioid prescription at ICU discharge [y/n] in patients discharged alive (as listed in the ICU discharge report) | Part A: at ICU discharge assessed up to 5 days |
| Opioid prescription at hospital discharge | - Opioid prescription at hospital discharge [y/n] in patients discharged alive (as listed in the hospital discharge report) | Part A: at hospital discharge assessed up to 10 days |
| Target nociception level | Target Pupillary Pain Index. The Pupillary Pain Index (PPI) is a scale with range from 1 to 9 indicating the pupillary response to a noxious stimulus. A lower value indicates a deeper nociception level (a more intense stimulus is necessary to trigger pupillary dilation). A higher value indicates a lighter nociception level (a less intense stimulus triggers pupillary dilation). | Part A: during mechanical ventilation (up to 28 days) |
| Opioid-free days in the ICU | Days free of opioid administration [%] | Part A: from ICU admission to ICU discharge (up to 100 days) |
| Pupillary Pain Index | Objective pain measurement of nociception level. The Pupillary Pain Index (PPI) is a scale with range from 1 to 9 indicating the pupillary response to a noxious stimulus. A lower value indicates a deeper nociception level (a more intense stimulus is necessary to trigger pupillary dilation). A higher value indicates a lighter nociception level (a less intense stimulus triggers pupillary dilation). | - Part A: During mechanical ventilation - Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5 |
| Cortisol | blood and saliva levels [nmol/L] | Part B: day 2/visit 2, day 3/visit 4 |
| Amylase | blood and saliva [U/L] | Part B: day 2/visit 2, day 3/visit 4 |
| Critical Care Pain Observation Tool (CPOT) | Validated behavioural pain assessment tool used in other intensive care units. The CPOT evaluates 4 dimensions. A score of 2 or less is regarded as likely minimal to no pain. A score of more than 2 is regarded as unacceptable level of pain. | Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5 |
| Subjective pain rating | Questionnaire based rating of pain [y/n] by physician and nurses | Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5 |
| Subjective rating of nociception level | Questionnaire based rating of nociception level [light/moderate/deep] by physician and nurses:
| Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5 |
| Trust in the Zurich Observational Pain Assessment (ZOPA) | Trust rated by ICU physicians and ICU nurses on a numeric scale with a range from 0 to 10. 0 indicates no trust in the ZOPA and 10 indicates maximal trust in the ZOPA. | Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5 |
| Trust in the Pupillary Pain Index (PPI) | Trust rated by ICU physicians and ICU nurses on a numeric scale with a range from 0 to 10. 0 indicates no trust in the PPI and 10 indicates maximal trust in the PPI. | Part B: day 2/visit 2, day 2/visit 3, day 3/visit 4, day 3/visit 5 |
| Pupil size before stimulation | Pupil size before stimulation PPI measurement [mm] | Part A: during mechanical ventilation (up to 28 days) |
| Percentage pupil's variation | Pupil variation [%] during PPI measurement | Part A: during mechanical ventilation (up to 28 days) |
| Maximal size variation | Maximal variation in pupil size [mm] during PPI measurment. | Part A: during mechanical ventilation (up to 28 days) |
| Neuron-specific Enolase (NSE) [mcg/L] | NSE [mcg/L] in patients after cardiac arrest at 24, 48 and 72 hours | Part A: From cardiac arrest until 72 hours after cardiac arrest |
| Part A: during mechanical ventilation (up to 28 days) |
| ICU mortality | [y/n] | Part A: from date of inclusion up to 100 days |
| ICU length of stay | in [days] | Part A: from date of inclusion up to 100 days |
| Duration of mechanical ventilation | in [days] | Part A: from date of inclusion up to 100 days |
| Hospital mortality | [y/n] | Part A: from date of inclusion up to 100 days |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |