AnesthesiaCOMFORTNCT03496493
COMparison of Portable Fingertip Versus Conventional Pulse OximeteRs Trial
An observational study of Anesthesia and Hypoxemia, run by University of Cape Town at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Hypoxemia
- What is being tested?
- All patients
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Apr 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult surgical patients presenting for elective or emergency surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Comparison of the Agreement Between a Portable Fingertip Pulse Oximeter Versus Conventional Bedside Pulse Oximeter in Adult Patients
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.
Read the detailed 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.
- Conditions
- Anesthesia, Hypoxemia
- Being tested
- All patients
- Keywords
- perioperative, monitoring, plethysmography, pulse oximetery
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patientsDevice
Also called Nihon-Kohden Lifescope BSM 3562 patient monitor, Contec CMS50D fingertip pulse oximeter
Peripheral arterial oxygen saturation recording with both study devices
| Study group | Role | What they receive |
|---|---|---|
| All patients | 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. Receives: Device: All patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 minute
Secondary outcomes (3)
Average root mean square difference
Average root mean square difference in saturation pairs between the oximeters of less than 3%
Measured: 1 minute
Skin tone effect
Subgroup analysis of effect of skin tone (Fitzpatrick scale) on oximeter agreement (provisional on adequate recruitment across groups)
Measured: 1 minute
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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start15 Apr 2018
- Primary completion11 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross Hofmeyr, University of Cape Town
- Investigators
- Ross Hofmeyr, FCA(SA), Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496493
- Sponsor's protocol ID
- UCT_Anaes_201801
- Acronym
- COMFORT
- Status last verified
- Feb 2019
- First submitted
- 20 Jan 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Raw study data will be uploaded to an open sharing platform (www.researchgate.org or similar) after publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Comparison of the Agreement Between a Portable Fingertip Pulse Oximeter Versus Conventional Bedside Pulse Oximeter in Adult Patients
- ClinicalTrials.gov ID
- NCT03496493
- Acronym / sponsor ID
- COMFORT / UCT_Anaes_201801
- Conditions
- Anesthesia, Hypoxemia
- Keywords
- perioperative, monitoring, plethysmography, pulse oximetery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: All patientsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Adult surgical patients presenting for elective or emergency surgery
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All patientsAlso: Nihon-Kohden Lifescope BSM 3562 patient monitor, Contec CMS50D fingertip pulse oximeterPeripheral arterial oxygen saturation recording with both study devices | Device | All patients |
Primary outcome
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).
3 secondary outcomes
Average root mean square difference
Time frame: 1 minute
Skin tone effect
Time frame: 1 minute
Perfusion (pulse magnitude) effect on oximeter agreement
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Hofmeyr, FCA(SA) principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Hypoxemia, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saturation measurement agreement (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.