Failure of Respiratory Function Clinical Trial
— PUPILLO REAOfficial title:
Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.
Sedation-analgesia is an important therapy for patients in resuscitation. It requires a
surveillance, in order to avoid excessive or insufficient dosages of sedative or
nonmorphinics, sources of side effects. Yet, means of surveillance are limited in
resuscitation care : variations of blood pressure and heart rate are not very sensitive
criterias. Clinical scales to measure the sedation and analgesia level were proposed for
patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural
pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive
stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients
under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold
by pupillometry for patients in resuscitation receiving a sedation-analgesia.
The main goal of this study is to measure the minimum intensity of a painful stimulation
(tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care
receiving sedation-analgesia continuously.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Intubated and Mechanically Ventilated Patients receiving by continuous intravenous an hypnotic sedation (midazolam or propofol) associate with a morphine type drug (fentanyl, sufentanil, rémifentanil, or morphine) since at least 6 hours and for a predictable duration over 24 hours. - Both gender - Adult over 18 years Exclusion Criteria: - Neuromuscular pathology that does not allow the use of clinical scales in order to measure sedation-analgesia : tetraplegia, resuscitation neuromyopathy, curares. - Intracranial hypertension (intracranial pressure over 20 mmHg) whatever the cause (traumatique, vasculaire, tumorale). - Dysautonomia altering the pupillary dilatation's reflex (RDP) : old diabetes with diabetic retinopathy, multiple sclerosis, systemic amylose. - Treatment in progress which may affect the pupillary dilatation's reflex (RDP) : antiemetic (droperidol, métoclopramide), alpha-2 agoniste (clonidine). - Ocular pathology - Opiate addiction - Refusal by a patient - Pregnant women |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | UniversityHospitalGrenoble | La Tronche |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
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* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of pupillary dilatation's reflex (RDP) | Vidéopupillometer Neurolight® | 13 seconds | No |