No registrations found.
ID
Source
Brief title
Health condition
Postoperative condition
Respiration
Monitoring
Postoperatieve conditie
Ademhaling
Monitoring
Sponsors and support
Intervention
Outcome measures
Primary outcome
The function of the IPI monitor and the number of IPI-events during the first day and night after after anesthesia and the use of opiods (ie. number of IPI events, IPI AUC) are the main end-points.
Secondary outcome
The secondary end-point is to get information to start another IPI-study in which the difference between the current protocol will be compared to treatment of respiratory problems using the IPI.
Additional data that is collected and may serve as covariate in the data analysis includes:
„PƒnPatient related parameters:
Sex; Weight; Age; BMI; Underlying disease; Comorbidity; Medication; OSAS (STOP
bang criteria).
„PƒnAnesthesia related parameters:
Anesthesia type (inhalational versus intravenous); use of NMB agent; use of reversal agent (neostigmine or sugammadex); ketamine use during anesthesia; use of epidural, spinal or local block; opioid type and dose.
„PƒnPain treatment (incl. dose):
Epidural or local anesthesia/analgesia; PCA morphine; Ketamine use; Oral opioids (oxycodone); SC opioid use (morphine).
„PƒnSurgery related parameters:
Surgery type; Duration of surgery; Blood loss.
„PƒnPost-op location:
Ward-recovery-PACU-ICU
Background summary
In 40 patients following elective surgery under general anesthesia that require opioid pain relief the IPI will be measured at the PACU (post anesthesia care unit) during the first postoperative night (end of study 8 AM 1st postoperative day). In these 40 patients the IPI will be measured but no action will be undertaken based on the IPI. Local protocol will be followed in which nurses base their decision to intervene (ie. stimulate the patient, call for help) on sedation level and respiratory rate. The study will generate data on the incidence of respiratory events in the study population to be potential used in a next IPI-study where the focus is on interventions as a result of the IPI.
Study objective
The main goal of the study is to assess the incidence of respiratory events using the IPI device.
Study design
The observation will start from the arrival of the patient on the PACU untill 8 am on the first postoperative day
Intervention
Postoperative respiratoir condition
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Inclusion criteria
Adult (> 17 years) ASA 1-3 patients that underwent elective surgery under general anesthesia who require opioid pain relief and are able to wear or retain the IPI device post-operatively.
Exclusion criteria
Patients having ENT, facial or neurological/ brain (head) surgery or are not able to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5231 |
| NTR-old | NTR5455 |
| Other | METC LUMC : P15.170 |