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The Integrated Pulmonary Index (IPI) for assessment of the postoperative respiratory condition


- candidate number22839
- NTR NumberNTR5455
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2015
- Secondary IDsP15.170 METC LUMC
- Public TitleThe Integrated Pulmonary Index (IPI) for assessment of the postoperative respiratory condition
- Scientific TitleThe Integrated Pulmonary Index (IPI) for assessment of the postoperative respiratory condition íV The IPI Study
- ACRONYMIPI study
- hypothesisThe main goal of the study is to assess the incidence of respiratory events using the IPI device.
- Healt Condition(s) or Problem(s) studiedPost operative, Monitoring
- Inclusion criteriaAdult (> 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 criteriaPatients having ENT, facial or neurological/ brain (head) surgery or are not able to give informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2015
- planned closingdate1-sep-2016
- Target number of participants40
- InterventionsPostoperative respiratoir condition
- Primary outcomeThe 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 outcomeThe 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:
äPânPatient related parameters:
Sex; Weight; Age; BMI; Underlying disease; Comorbidity; Medication; OSAS (STOP bang criteria).
äPânAnesthesia 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.
äPânPain treatment (incl. dose):
Epidural or local anesthesia/analgesia; PCA morphine; Ketamine use; Oral opioids (oxycodone); SC opioid use (morphine).
äPânSurgery related parameters:
Surgery type; Duration of surgery; Blood loss.
äPânPost-op location:
Ward-recovery-PACU-ICU
- TimepointsThe observation will start from the arrival of the patient on the PACU untill 8 am on the first postoperative day
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Covidien Nederland
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD7-sep-2015 - 22-nov-2015


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