COMparison of Portable Fingertip Versus Conventional Pulse OximeteRs Trial

NCT03496493 | Completed FDA Device

• 1 other identifier: UCT_Anaes_201801
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Hypoxemia

Keywords

perioperative; monitoring; plethysmography; pulse oximetery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Average root mean square difference

  1 minute

• Skin tone effect

  1 minute

• Perfusion (pulse magnitude) effect on oximeter agreement

  1 minute

Study Arms (1)

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.

Device: All patients

Interventions

All patients DEVICE

Peripheral arterial oxygen saturation recording with both study devices

Also known as: Nihon-Kohden Lifescope BSM 3562 patient monitor, Contec CMS50D fingertip pulse oximeter

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adult surgical patients presenting for elective or emergency surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ross Hofmeyr, FCA(SA)

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept Anaesthesia & Perioperative Medicine

Study Record Dates

• First Submitted: January 20, 2018
• First Posted: April 12, 2018
• Study Start: April 15, 2018
• Primary Completion: June 11, 2018
• Study Completion: December 31, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of the study, to remain available indefinitely.
• Access Criteria: Open access after publication

Locations

ZA (1)