Importance of Integrated Pulmonary Index in Pediatric Endoscopy
NCT ID: NCT05137574
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-05-10
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Group P
Patients sedated with propofol
Integrated Pulmonary Index (IPI) monitoring
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
propofol
Group K
Patients sedated with ketamine
Integrated Pulmonary Index (IPI) monitoring
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.
ketamine
ketamine
Interventions
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Integrated Pulmonary Index (IPI) monitoring
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
propofol
ketamine
ketamine
Eligibility Criteria
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Inclusion Criteria
* Elective upper or lower gastrointestinal tract endoscopy
Exclusion Criteria
* Patients with any contraindication for off-site anesthesia
1 Month
18 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Ruslan Abdullayev
Assist. Prof.
Principal Investigators
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Ruslan Abdullayev
Role: PRINCIPAL_INVESTIGATOR
Marmara University Department of Anesthesiology and Reanimation
Locations
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Marmara University School of Medicine
Istanbul, Pendik, Turkey (Türkiye)
Countries
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References
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Taft A, Ronen M, Epps C, Waugh J, Wales R. A Novel Integrated Pulmonary Index (IPI) quantifies heart rate, etCO2, respiratory rate and SpO2%. ASA A1682, 22 Oct 2008.
Berkenstadt H, Ben-Menachem E, Herman A, Dach R. An evaluation of the Integrated Pulmonary Index (IPI) for the detection of respiratory events in sedated patients undergoing colonoscopy. J Clin Monit Comput. 2012 Jun;26(3):177-81. doi: 10.1007/s10877-012-9357-x. Epub 2012 Mar 28.
Riphaus A, Wehrmann T, Kronshage T, Geist C, Pox CP, Heringlake S, Schmiegel W, Beitz A, Meining A, Muller M, von Delius S. Clinical value of the Integrated Pulmonary Index(R) during sedation for interventional upper GI-endoscopy: A randomized, prospective tri-center study. Dig Liver Dis. 2017 Jan;49(1):45-49. doi: 10.1016/j.dld.2016.08.124. Epub 2016 Sep 1.
Garah J, Adiv OE, Rosen I, Shaoul R. The value of Integrated Pulmonary Index (IPI) monitoring during endoscopies in children. J Clin Monit Comput. 2015 Dec;29(6):773-8. doi: 10.1007/s10877-015-9665-z. Epub 2015 Feb 11.
Other Identifiers
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09.2021.511
Identifier Type: -
Identifier Source: org_study_id