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Clinical trial

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

ID
Name
09.2021.497
Description
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.
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-02-01
Trial end
2023-02-01
Status
Completed
Treatment
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.
Arms:
Group K, Group P
propofol
propofol
Arms:
Group P
ketamine
ketamine
Arms:
Group K
Size
60
Primary endpoint
IPI-Ketamine
Throughout the sedation procedure
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-02-28

1 organization

1 product

1 drug

2 indications

Organization
Marmara University
Product
propofol
Indication
Monitored Anesthesia Care
Indication
Respiratory Monitoring
Drug
Ketamine