Ventilator Lung; Newborn Clinical Trial
— NIPEOfficial title:
Official Title Evaluation of the Value of Newborn Infant Parasympathetic Evaluation (NIPE) in Sedated/Ventilated Patients in Pediatric Intensive Care Unit
NCT number | NCT04195672 |
Other study ID # | NI2019_ |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | April 30, 2019 |
Verified date | December 2019 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The main objective is to assess correlation between Newborn Infant Parasympathetic Index values and external evaluation by Comfort Behaviour Scale during painful medical cares in sedated intubated children admitted in pediatric intensive care unit.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Years |
Eligibility |
Inclusion Criteria: - All consecutive patient = 3 year-old, mechanically ventilated Exclusion Criteria: - Withdraw life-support, - unstable condition preventing planned routine procedures of care, - conditions precluding the use of NIPE (cardiac transplant, absence of sinus cardiac rhythm, apnea or respiratory rate = 25 /min, pacemaker and use of atropine and/or isoprenaline and conditions of days of availability for NIPE) |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Jeanne de Flandres, CHU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Newborn Infant Parasympathetic Evaluation | Comparison between Newborn Infant Parasympathetic Evaluation values (0 to 100) and Comfort Behaviour Scale values (8 to 40) assessed by coefficient of correlation in patients upper than three years old | Through the study completion (18 months) | |
Primary | Comfort Behaviour Scale | Comparison between Newborn Infant Parasympathetic Evaluation values (0 to 100) and Comfort Behaviour Scale values (8 to 40) assessed by coefficient of correlation in patients upper than three years old | Through the study completion (18 months) | |
Secondary | Newborn Infant Parasympathetic Evaluation | Determination of pain detection threshold with Newborn Infant Parasympathetic Evaluation scale (0 to 100) using receiving operator characteristics (ROC) curve | Through the study completion (18 months) |
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