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NCT03021551 · ClinicalTrials.gov registry record
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients
A clinical trial of Surgery and Morbid Obesity, sponsored by Masimo Corporation.
- Completed
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT03021551: Completed study of Surgery and Morbid Obesity, sponsored by Masimo Corporation.
NCT03021551 is a study of Surgery and Morbid Obesity that has completed, run by Masimo Corporation. The registered enrollment target is 80 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03021551, a study of Surgery and Morbid Obesity, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to partial pressure of oxygen (PaO2) values of 100 mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200 mmHg and above. This is clinical study designed to evaluate the clinical utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin desaturation during the induction of general anesthesia and tracheal intubation in obese patients undergoing elective surgical procedures.
Primary Outcome
Evaluate the clinical utility of the change in the oxygen reserve index as an early warning of impending arterial oxygen desaturation in Obese patients (30 \< BMI \< 40 kg m-2) and Normal BMI patients (19 \< BMI \< 25 kg m-2).
Conditions Studied
Interventions
- DEVICE Rainbow sensor
Study Locations (1)
California
- UC Davis Health - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-09-15 |
| Est. Completion | 2018-07-20 |
What the finished NCT03021551 record still lists
NCT03021551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Surgery appearing as the primary indexed condition, and to 1 intervention - of which Rainbow sensor is the first listed.
NCT03021551 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03021551 about?
NCT03021551 is a clinical study titled "Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients". The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to partial pressure of oxygen (PaO2) values of 100 mmHg and below and an O...
What is the current status of trial NCT03021551?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2016-09-15. Estimated completion is 2018-07-20.
What conditions does trial NCT03021551 study?
This clinical trial studies the following conditions: Surgery, Morbid Obesity.
What interventions are being tested in trial NCT03021551?
The interventions under investigation include: Rainbow sensor (DEVICE).
Who is sponsoring clinical trial NCT03021551?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03021551 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03021551's enrollment target sits among peer trials
80 67th of 120 higher than 49 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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