COMFORT
Perioperative Comparison of the Agreement Between a Portable Fingertip Pulse Oximeter Versus Conventional Bedside Pulse Oximeter in Adult Patients
Sponsor study identifier
observational
220
1 country
1
Study Start
April 15, 2018
Actual (reported)Primary Completion
June 11, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Perioperative non-invasive measurement of a patient's peripheral arterial oxygen saturation has become an accepted standard of care endorsed by anaesthesiologists and their regulatory bodies throughout the world. Pulse oximeters are an integral item on the World Health Organisation's Surgical Safety Checklist which is performed prior to the commencement of every surgical procedure. They are also utilised by other medical professionals and patients in various scenarios. When compared to conventional bedside pulse oximeters, portable fingertip devices have the advantages of cost-effectiveness, high portability, ease of use and battery operation. A review of recent literature reveals a paucity of accuracy studies in adult patients with various comorbidities in the clinical setting. Most data has been obtained under ideal laboratory conditions utilizing healthy adult volunteers. This study aims to pragmatically investigate the performance of a portable fingertip pulse oximeter in adult patients in a hospital setting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2018
Actual (reported)April 12, 2018
Actual (reported)April 15, 2018
Actual (reported)June 11, 2018
Actual (reported)December 31, 2018
Actual (reported)Saturation measurement agreement
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).
1 minute
Average root mean square difference
1 minute
Skin tone effect
1 minute
Perfusion (pulse magnitude) effect on oximeter agreement
1 minute
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.
Peripheral arterial oxygen saturation recording with both study devices
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All adult surgical patients presenting for elective or emergency surgery within an academic teaching hospital. Patients will have measurements made in the perioperative period in areas where conventional monitoring of pulse oximetery occurs, such as anaesthesia preassessment areas, induction rooms, operating theatres, recovery areas, ICU and PAHCU.
Groote Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
Ross Hofmeyr, FCA(SA)
University of Cape Town
220 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2018
First Posted
April 12, 2018
Study Start
April 15, 2018
Actual (reported)Virtual Reality Hypnosis Distraction Utility to Improve Tolerance to Regional Anaesthesia
Contact the study team to confirm eligibility.
Primary Completion
June 11, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Last Updated
February 21, 2019
Record last verified: 2019-02
Raw study data will be uploaded to an open sharing platform (www.researchgate.org or similar) after publication of the study.
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Source: ClinicalTrials.gov.
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