Importance of Integrated Pulmonary Index in Pediatric Endoscopy

Monitored Anesthesia Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137574
• Other study ID #: 09.2021.511
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Monitored Anesthesia Care
• Respiratory Monitoring

Intervention

Device:
• 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.

Drug:
• propofol
propofol
• ketamine
ketamine

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPI-Ketamine	Correlation of ketamine and IPI values	Throughout the sedation procedure