COMparison of Portable Fingertip Versus Conventional Pulse OximeteRs Trial (COMFORT)
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|ClinicalTrials.gov Identifier: NCT03496493|
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment|
|Anesthesia Hypoxemia||Device: All patients|
The purpose of this prospective, quantitative study is to compare the agreement between the measured arterial oxygen saturation levels using a portable fingertip versus a conventional bedside pulse oximeter in adult surgical patients, presenting for elective and emergency surgery to Groote Schuur Hospital over a four-week period. Adult surgical patients, not meeting any exclusion criteria, who present for elective or emergency surgery will be recruited. 200 data pairs (SpO2, heart rate and skin tone) will be recorded in the perioperative period (operating rooms, recovery room and intensive care unit).
Existing monitoring devices will not be disturbed. The agreement between the two devices will be compared using a Bland-Altman plot, Microsoft Excel and SPSS software. A root mean square difference value will also be calculated from these values.
No sensitive or personal patient information will be recorded, and pulse oximetry is essential harmless. Potential cross-infection will be avoided by excluding patients with known communicable diseases or open wounds/ bodily fluids in the area to have the oximeter probes applied. The study devices will be disinfected after each use. Recruitment will not affect clinical care.
The significance of this study into the performance of portable fingertip pulse oximeters in adult surgical patients will result in the availability of cheaper devices, deemed as vital anaesthetic equipment by the WHO and various anaesthetic regulatory bodies, in lower income medical facilities. It will also give anaesthetists and other medical personal the confidence to make clinical decisions based on these highly portable devices, thereby making pulse oximeters more available in resource limited areas. It will also add further data to existing studies and help assess whether darker skin pigment affects the performance of these devices in the clinical setting, which is highly relevant in an African country like South Africa.
|Study Type :||Observational|
|Actual Enrollment :||220 participants|
|Official Title:||Perioperative Comparison of the Agreement Between a Portable Fingertip Pulse Oximeter Versus Conventional Bedside Pulse Oximeter in Adult Patients|
|Actual Study Start Date :||April 15, 2018|
|Actual Primary Completion Date :||June 11, 2018|
|Actual Study Completion Date :||December 31, 2018|
All patients enrolled in trial will have peripheral oxygen saturation simultaneously recorded with both study devices on non-adjacent (second and fourth) fingers of the same hand.
Device: All patients
Peripheral arterial oxygen saturation recording with both study devices
- Saturation measurement agreement [ Time Frame: 1 minute ]Bland-Altman analysis of saturation measurement pairs, with a priori acceptable limits of agreement (1.96 x SD measurement differences) within 3%. This is in accordance with ISO and FDA guidelines for testing of these devices (see relevant standard).
- Average root mean square difference [ Time Frame: 1 minute ]Average root mean square difference in saturation pairs between the oximeters of less than 3%
- Skin tone effect [ Time Frame: 1 minute ]Subgroup analysis of effect of skin tone (Fitzpatrick scale) on oximeter agreement (provisional on adequate recruitment across groups)
- Perfusion (pulse magnitude) effect on oximeter agreement [ Time Frame: 1 minute ]Subgroup analysis of effect of magnitude of pulse waveform signal (as an indication of finger perfusion on oximeter agreement. This will be graded qualitatively as good, poor, or absent waveform, and is provisional on adequate recruitment across groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496493
|Groote Schuur Hospital|
|Cape Town, Western Cape, South Africa, 7925|
|Principal Investigator:||Ross Hofmeyr, FCA(SA)||University of Cape Town|