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

The Integrated Pulmonary Index (IPITM) for assessment of the postoperative respiratory condition * The IPI Study - IPI study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47416

Enrollment

120

Registered

2015-08-27

Start date

2016-04-13

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

postoperatieve conditie postoperative condition

Interventions

Based on IPI values, see above.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients eligible to participate in the study are adult (> 17 years) ASA 1-3 patients that underwent elective surgery under general anesthesia and that require opioid pain relief.

Exclusion criteria

Exclusion criteria: Patients having ENT (ear-nose-throat), facial or brain (head) surgery or who are not able to give informed consent. There are no other specific contraindications for participation.

Design outcomes

Primary

Measure	Time frame
The IPI values (ie. number of IPI events	—

Secondary

Measure	Time frame
Secondary end-points are the 4 relevant variables: EtCO2, heart rate, respiratory rate and SpO2. Additional data that is collected and may serve as covariate in the data analysis includes: Patient related parameters: Sex; Weight; Age; BMI; Underlying disease; Comorbidity; Medication; OSAS (STOP bang criteria). Anesthesia 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; opioi type and dose. Pain treatment (incl. dose): Epidural or local anesthesia/analgesia; PCA morphine; Ketamine use; Oral opioids (oxycodone); SC opioid use (morphine). Surgery related parameters: Surgery type; Duration of surgery; Blood loss. **Post-op location: Ward-recovery-PACU-ICU Amendment: patients will have the Elfitor device on the hand, which is a non-invasive monitor of nociception through autonomic parameter analyses.	—

Measure

Time frame

Secondary end-points are the 4 relevant variables: EtCO2, heart rate, respiratory rate and SpO2. Additional data that is collected and may serve as covariate in the data analysis includes: **Patient related parameters: Sex; Weight; Age; BMI; Underlying disease; Comorbidity; Medication; OSAS (STOP bang criteria). **Anesthesia 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; opioi type and dose. **Pain treatment (incl. dose): Epidural or local anesthesia/analgesia; PCA morphine; Ketamine use; Oral opioids (oxycodone); SC opioid use (morphine). **Surgery related parameters: Surgery type; Duration of surgery; Blood loss. **Post-op location: Ward-recovery-PACU-ICU Amendment: patients will have the Elfitor device on the hand, which is a non-invasive monitor of nociception through autonomic parameter analyses.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)