- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07648342
Evaluation of Pupillometry as a Predictor of Pain Intensity Upon Withdrawal of Sedation in the Postoperative Period Following Cardiac Surgery: A Prospective Cohort Study (PUPREA)
Postoperative pain is a significant issue following surgery, and pain that is either inadequately treated or, conversely, overtreated can increase morbidity. For example, severe chest pain following cardiac or pulmonary surgery impairs the patient's respiratory rehabilitation, which can lead to fluid retention and, consequently, pneumonia. Conversely, overtreatment through excessive use of opioids can cause drowsiness and respiratory depression. Currently, planning postoperative pain management for intubated, ventilated, and sedated patients relies on indirect signs of pain assessed using scales, and on the clinician's subjective judgment. It is only after sedation is discontinued that the actual level of pain can be assessed, once the patient becomes communicative, which then allows analgesic treatment to be adjusted to the pain. This approach inevitably results in a period of discomfort and pain for the patient. In addition to semi-quantitative and subjective scales, a number of analgesia monitoring tools have been developed.
Among these, the use of pupillometry and the Pupillary Pain Index (PPI) during surgeries (gynecological, pediatric, cardiac) has been associated with a reduction in intraoperative opioid doses and a decrease in postoperative pain. In our department, pupillometry is routinely used to assess analgesia in intubated, ventilated, and sedated patients undergoing painful procedures. This method is integrated into standard care in the operating room in accordance with the PUCCAR study algorithm, as well as in the intensive care unit according to a specific departmental protocol, in addition to standard assessment scores. We hypothesize that performing pupillometry with a PPI score is predictive of pain intensity at extubation. If our hypothesis is confirmed, this would allow us to tailor analgesic management for each patient prior to discontinuing sedation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Vivien BERTHOUD
- Telefonnummer: +33 06.72.76.00.74
- E-mail: vivien.berthoud@gmail.com
Studiesteder
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Dijon, Frankrig, 21000
- Chu Dijon Bourogne
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Kontakt:
- Vivien BERTHOUD
- Telefonnummer: +33 06.72.76.00.74
- E-mail: vivien.berthoud@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- A person who has given verbal consent
- An adult patient
- A patient scheduled for heart surgery
Exclusion Criteria:
- A person who is not enrolled in or eligible for a social security program
- A person subject to a legal protective measure (guardianship, conservatorship)
- Person subject to a judicial safeguard measure
- Pregnant, laboring, or breastfeeding woman
- Adult who is legally incapacitated or unable to give consent
- Minor
- Patient with preoperative cognitive impairment (MMS)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Patients scheduled for heart surgery
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Conducting pupillometry with a PPI score upon discontinuation of sedation in the intensive care unit
Measurement of pain intensity using the visual analog scale (VAS ou EVA)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pain assessment using a visual analog scale
Tidsramme: Immediately after surgery
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First VAS (Visual Analog Scale, 0-10) measurement taken 5 to 15 minutes after extubation, as soon as the patient is able to communicate reliably.
Dichotomous variable: VAS >3 (severe pain) versus VAS ≤3 (tolerable pain).
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Immediately after surgery
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BERTHOUD 2026
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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