Importance of Integrated Pulmonary Index in Pediatric Endoscopy
- Conditions
- Monitored Anesthesia CareRespiratory Monitoring
- Interventions
- Registration Number
- NCT05137574
- Lead Sponsor
- Marmara University
- 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 endoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA 1-3 physical status
- Elective upper or lower gastrointestinal tract endoscopy
- ASA physical status of 4 or more
- Patients with any contraindication for off-site anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group K Integrated Pulmonary Index (IPI) monitoring Patients sedated with ketamine Group P Integrated Pulmonary Index (IPI) monitoring Patients sedated with propofol Group P propofol Patients sedated with propofol Group K ketamine Patients sedated with ketamine
- Primary Outcome Measures
Name Time Method IPI-Ketamine Throughout the sedation procedure Correlation of ketamine and IPI values
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Marmara University School of Medicine
🇹🇷Istanbul, Pendik, Turkey