COMparison of Portable Fingertip Versus Conventional Pulse OximeteRs Trial

Anesthesia Clinical Trial

— COMFORT  

Official title:

Perioperative Comparison of the Agreement Between a Portable Fingertip Pulse Oximeter Versus Conventional Bedside Pulse Oximeter in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496493
• Other study ID #: UCT_Anaes_201801
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 31, 2018
• Est. primary completion date: June 11, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult surgical patients presenting for elective or emergency surgery

Exclusion Criteria:

• Contact precautions due to high risk of transmissable infectious disease

• Significant hypotension or hypoperfusion (systolic blood pressure <80 mmHg, or hypothermia)

• Motion artefacts due to excessive patient movements

• Known presence of variant haemoglobin species (eg. carboxy- or methaemoglobin)

• Intraoperative dye use (eg. methylene blue or indocyanine green)

• Nail polish or black henna

• Tape or bandages over the fingers

• Absent/inadequate pulse oximetry tracing on existing monitor

Related Conditions & MeSH terms

• Anesthesia
• Hypoxemia
• Hypoxia

Intervention

Device:
• All patients
Peripheral arterial oxygen saturation recording with both study devices

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Average root mean square difference	Average root mean square difference in saturation pairs between the oximeters of less than 3%	1 minute
Secondary	Skin tone effect	Subgroup analysis of effect of skin tone (Fitzpatrick scale) on oximeter agreement (provisional on adequate recruitment across groups)	1 minute
Secondary	Perfusion (pulse magnitude) effect on oximeter agreement	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.	1 minute