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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28414

Enrollment

Registered

2015-09-07

Start date

2015-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative condition Respiration Monitoring Postoperatieve conditie Ademhaling Monitoring

Interventions

Postoperative respiratoir condition

Eligibility

Inclusion criteria

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

Exclusion criteria: Patients having ENT, facial or neurological/ brain (head) surgery or are not able to give informed consent.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)