Importance of Integrated Pulmonary Index in Pediatric Bronchoscopy

Brief Summary

Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements. In this study, we wanted to evaluate the value of IPI in cases of pediatric bronchoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Intervention / Treatment

  • Integrated Pulmonary Index (IPI) monitoring (DEVICE)
    Integrated Pulmonary Index (IPI) monitor will be applied to the patients, to provide numerical data obtained from the measurements of end-tidal carbon dioxide, respiratory rate, oxygen saturation measured by pulse oximetry (SpO2), and pulse rate.
  • Propofol (DRUG)
    propofol
  • Ketamine (DRUG)
    ketamine

Condition or Disease

  • Monitored Anesthesia Care
  • Respiratory Monitoring

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 1 Month to 18 Years
    Enrollment: 60 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Diagnostic

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2022 ACTUAL
    Primary Completion: Feb 01, 2023 ACTUAL
    Completion Date: Feb 01, 2023 ACTUAL
    Study First Posted: Nov 30, 2021 ACTUAL
    Last Updated: Feb 27, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    Bronchoscopy is a procedure that is frequently applied in diagnostic or interventional conditions like hemoptysis, tracheobronchial stenosis, malignancy, recurrent lung infections, etc. It is routinely performed under general anesthesia or sedation in pediatric cases. In our clinic, we routinely perform diagnostic or interventional pediatric bronchoscopy procedures with an anesthesia team outside the operating room under monitored anesthetic care (MAC). Routine monitoring of MAC consists of electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). These monitorizations are described as minimum in many practice guidelines, and sometimes monitors such as end-tidal carbon dioxide (ETCO2), body temperature, analgesia/nociception index (ANI) can be added to them.

    Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2).(1,2) When these parameters exceed physiological limits, patients require interventions consisting of various maneuvers or drug administration in order to maintain the normal functioning of the cardiorespiratory system. If we look at the scoring, a score of 8-10 is considered normal, a score of 5-7 indicates a situation that may require intervention, and a score of 1-4 indicates that the patient needs intervention.

    The above-mentioned IPI is a relatively new tool, and there is limited data in the literature regarding its usability in patients undergoing interventional procedures under MAC.(3,4) In this study, we wanted to evaluate the safety of IPI in cases of pediatric bronchoscopy performed under sedation. Routine monitoring and drug applications for the procedure will be in accordance with the institutional protocols, and additional IPI monitoring will be performed. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

    Participant Groups

    • Patients sedated with propofol

    • Patients sedated with ketamine

    Eligibility Criteria

    Sex: All
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA 1-3 physical status
    * Elective upper or lower gastrointestinal tract endoscopy

    Exclusion Criteria:

    * ASA physical status of 4 or more
    * Patients with any contraindication for off-site anesthesia

    Primary Outcomes
    • Correlation of ketamine and IPI values

    More Details

    NCT Number: NCT05137587
    Other IDs: 09.2021.497
    Study URL: https://clinicaltrials.gov/study/NCT05137587
    Last updated: Sep 29, 2023