Importance of Integrated Pulmonary Index in Pediatric Endoscopy

Study Overview
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Brief Summary
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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 endoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Detailed Description
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Upper gastrointestinal system (GIS) endoscopy is a common diagnostic or interventional procedure in cases such as foreign body ingestion, gastritis, peptic ulcer, esophagitis, esophageal variceal bleeding. Lower GIS endoscopy is a procedure performed in cases such as Crohn's or Ulcerative Colitis diseases, colon polyps, diverticular disease. It is routinely performed under general anesthesia or sedation in pediatric cases. In our clinic, we routinely perform diagnostic or interventional pediatric upper and lower endoscopy procedures with the non-operating room anesthesia team 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. The 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 endoscopy 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.

Official Title
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Importance of Integrated Pulmonary Index in Pediatric Patients Undergoing Endoscopy Procedures Under Sedation

Conditions
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Monitored Anesthesia Care, Respiratory Monitoring

Intervention / Treatment
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* Device: Integrated Pulmonary Index (IPI) monitoring
* Drug: propofol
* Drug: ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group P<br>Patients sedated with propofol | Device: Integrated Pulmonary Index (IPI) monitoring<br>* 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.<br>Drug: propofol<br>* propofol<br>|
| Active Comparator: Group K<br>Patients sedated with ketamine | Device: Integrated Pulmonary Index (IPI) monitoring<br>* 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.<br>Drug: ketamine<br>* ketamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPI-Ketamine | Correlation of ketamine and IPI values | Throughout the sedation procedure |