Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270264
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2024-02-05
Brief Title:
Nociception Monitoring in Intensive Care
Sponsor:
Haseki Training and Research Hospital
Organization:
Haseki Training and Research Hospital
Study Overview
Official Title:
Nociception Level Index Guidance for Analgesia in Pressure Ulcer Care in Unconscious Patients A Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Precisely pain in the ICU is a multidimensional problem with a multivariate of reasons Still it would be simpler to manage it in unconscious palliative patients with less source of pain but only if we can detect it practically with the help of nociception monitors Using five parameters nociception level index NOL monitoring Medasense is differentiated from its alternatives Other than pain detection this monitoring can titrate analgesic administration This study investigates the validity of a new nociception monitoring tool the nociception level index and its practical impact on providing adequate analgesia in palliative patients in intensive care
Detailed Description:
The study design is randomized prospective and controlled in the setting of a level two intensive care unit 40 patients n20 were randomized into control and nociception level During daily pressure ulcer care the nociception group received analgesia according to nociception level index monitorization and the control group had the same protocol as fentanyl bolus doses of 1mcqkg due to critical care observation pain tool assessment scores Secondarily hemodynamic values and variability were evaluated
Randomization was designed by a computer-based algorithm in a 11 ratio into 2 n 20 named Group NOL and Group Control and sealed into opaque envelopes When the inclusionexclusion criteria are met at the scheduled time of wound care the caregiver nurse in the ICU chooses one envelope to apply the designed protocol for each group
Study Intervention Caregiver nurses in the ICU were educated by the responsible doctor BC regarding the procedures after selecting study groups In our ICU unit routine patient care and simultaneous pressure ulcer interventions are done twice daily as day and night sessions In our study the caregiver nurse observed hemodynamic variables and CPOT values for pain evaluation 30 minutes before the day session of care and administered tramadol 1 mgkg routinely If CPOT values were still high then one mcqkg bolus of fentanyl at each time would be applied and repeated at five-minute intervals if necessary during care and 30 minutes after Hemodynamic variables and CPOT values were noted as before during and after care for all patients within two groups along with stages of pressure ulcers and all patients had standardized care procedures Notably in Group NOL patients the caregiver nurse assessed pain by NOL monitorization along with CPOT and hemodynamic variables and applied the same analgesia protocol by deciding analgesic need if NOL 25 over one minute at the monitor
Primary outcome The total amount of analgesia for every patient was noted as the total amount of analgesic drugs used to be stated separately as tramadol and fentanyl within the period starting from 30 minutes before until 30 minutes aftercare Although the total amount of tramadol used was in standardized protocols as 1 mg kg it was also investigated to refrain misevaluation due to overtreatment
Secondary outcome Heart rate and blood pressure changes before and after care were evaluated within groups and delta values calculated as the difference between the values at the beginning of ulcer care and before were also noted to question the effect of NOL monitorization on hemodynamic stability
Randomization was designed by a computer-based algorithm in a 11 ratio into 2 n 20 named Group NOL and Group Control and sealed into opaque envelopes When the inclusionexclusion criteria are met at the scheduled time of wound care the caregiver nurse in the ICU chooses one envelope to apply the designed protocol for each group
Study Intervention Caregiver nurses in the ICU were educated by the responsible doctor BC regarding the procedures after selecting study groups In our ICU unit routine patient care and simultaneous pressure ulcer interventions are done twice daily as day and night sessions In our study the caregiver nurse observed hemodynamic variables and CPOT values for pain evaluation 30 minutes before the day session of care and administered tramadol 1 mgkg routinely If CPOT values were still high then one mcqkg bolus of fentanyl at each time would be applied and repeated at five-minute intervals if necessary during care and 30 minutes after Hemodynamic variables and CPOT values were noted as before during and after care for all patients within two groups along with stages of pressure ulcers and all patients had standardized care procedures Notably in Group NOL patients the caregiver nurse assessed pain by NOL monitorization along with CPOT and hemodynamic variables and applied the same analgesia protocol by deciding analgesic need if NOL 25 over one minute at the monitor
Primary outcome The total amount of analgesia for every patient was noted as the total amount of analgesic drugs used to be stated separately as tramadol and fentanyl within the period starting from 30 minutes before until 30 minutes aftercare Although the total amount of tramadol used was in standardized protocols as 1 mg kg it was also investigated to refrain misevaluation due to overtreatment
Secondary outcome Heart rate and blood pressure changes before and after care were evaluated within groups and delta values calculated as the difference between the values at the beginning of ulcer care and before were also noted to question the effect of NOL monitorization on hemodynamic stability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None