Correlation of ketamine and IPI values
Importance of Integrated Pulmonary Index in Pediatric Bronchoscopy
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 bronchoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.
Intervention / Treatment
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Integrated Pulmonary Index (IPI) monitoring (DEVICE)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.
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Propofol (DRUG)propofol
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Ketamine (DRUG)ketamine
Condition or Disease
- Monitored Anesthesia Care
- Respiratory Monitoring
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 1 Month to 18 Years |
Enrollment: | 60 (ACTUAL) |
Allocation: | Randomized |
Primary Purpose: | Diagnostic |
MaskingTRIPLE:
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Clinical Trial Dates
Start date: | Sep 01, 2022 | ACTUAL |
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Primary Completion: | Feb 01, 2023 | ACTUAL |
Completion Date: | Feb 01, 2023 | ACTUAL |
Study First Posted: | Nov 30, 2021 | ACTUAL |
Last Updated: | Feb 27, 2023 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Bronchoscopy is a procedure that is frequently applied in diagnostic or interventional conditions like hemoptysis, tracheobronchial stenosis, malignancy, recurrent lung infections, etc. It is routinely performed under general anesthesia or sedation in pediatric cases. In our clinic, we routinely perform diagnostic or interventional pediatric bronchoscopy procedures with an anesthesia team outside the operating room 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.
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 bronchoscopy 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.
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 bronchoscopy 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.
Participant Groups
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Patients sedated with propofol
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Patients sedated with ketamine
Eligibility Criteria
Sex: | All |
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Maximum Age: | 18 |
Age Groups: | Child / Adult |
Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
More Details
NCT Number: | NCT05137587 |
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Other IDs: | 09.2021.497 |
Study URL: | https://clinicaltrials.gov/study/NCT05137587 |
Last updated: Sep 29, 2023