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Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial)
Background: Low-cost, portable fingertip pulse oximeters are widely available to health professionals and the public. They are often not tested to ISO standards, or only undergo accuracy studies in healthy volunteers under ideal laboratory conditions. This study aims to pragmatically evaluate the ag...
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| Format: | Thesis |
| Language: | English |
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Department of Anaesthesia and Perioperative Medicine
2019
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| _version_ | 1867613251587538944 |
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| access_status_str | Open Access |
| author | Smith, Reuben Nathanael |
| author2 | Hofmyer, Ross |
| author_browse | Hofmyer, Ross Smith, Reuben Nathanael |
| author_facet | Hofmyer, Ross Smith, Reuben Nathanael |
| author_sort | Smith, Reuben Nathanael |
| collection | Thesis |
| description | Background: Low-cost, portable fingertip pulse oximeters are widely available to health professionals and the public. They are often not tested to ISO standards, or only undergo accuracy studies in healthy volunteers under ideal laboratory conditions. This study aims to pragmatically evaluate the agreement between one such device and a conventional bedside pulse oximeter in a clinical setting, in patients with varied comorbidities and skin pigmentations. Methods: A single-centre equipment comparison study was conducted. Simultaneous measurements were obtained in 220 patients with both a Contec CMS50D Fingertip Pulse Oximeter and a Nihon Kohden Life Scope MU-631 RK conventional bedside monitor. Peripheral oxygen saturations (SpO₂) and pulse rates were documented, and patient skin tone was recorded using the Fitzpatrick scale. Data was assessed using a Bland-Altman analysis with bias, precision and limits of agreement (LOA) calculated with 95% confidence intervals. A priori acceptability for LOA was determined to be 3%, in keeping with international standards. Results: Mean difference (therefore bias) between the conventional and fingertip oximeters for all data was -0,55% (95% CI -0,73 to -0,36%). Upper and lower limits of agreement (95% CI) were 2,16 (1,84 to 2,47) and -3,25 (-3,56 to -2,94) %. Regression analysis demonstrated worsening agreement with decreasing SpO₂. When samples were separated into “normal” (SpO₂ ≥ 93%) and “hypoxaemic” (SpO₂ < 93%) groups, the normal range displayed acceptable agreement between the two oximeters (bias -0,20 with LOA 2,20 to -2,27%), while the hypoxaemic group fell outside the study’s a priori limits. Heart rate measurements had mean difference (LOA) of -0,43 (-5,61 to 4,76) beats per minute. The study was not powered to detect difference among the skin tones, but demonstrated no trend for this parameter to alter the SpO₂ measurements. Conclusions: During normoxia, portable fingertip pulse oximeters are reliable indicators of SpO₂ and pulse rates in patients with various comorbidities in a pragmatic clinical context. However, they display worsening agreement with conventional pulse oximeters during hypoxaemia. Skin tones do not appear to adversely affect measurements. |
| format | Thesis |
| id | oai:open.uct.ac.za:11427/29680 |
| institution | University of Cape Town (South Africa) |
| language | eng |
| last_indexed | 2026-06-10T12:33:10.259Z |
| license_str | Not specified — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from UCTD — University of Cape Town Open Access Repository |
| publishDate | 2019 |
| publishDateRange | 2019 |
| publishDateSort | 2019 |
| publisher | Department of Anaesthesia and Perioperative Medicine |
| publisherStr | Department of Anaesthesia and Perioperative Medicine |
| record_format | dspace |
| source_str | UCTD — University of Cape Town Open Access Repository |
| spelling | oai:open.uct.ac.za:11427/29680 Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) Smith, Reuben Nathanael Hofmyer, Ross Anaesthesiology Background: Low-cost, portable fingertip pulse oximeters are widely available to health professionals and the public. They are often not tested to ISO standards, or only undergo accuracy studies in healthy volunteers under ideal laboratory conditions. This study aims to pragmatically evaluate the agreement between one such device and a conventional bedside pulse oximeter in a clinical setting, in patients with varied comorbidities and skin pigmentations. Methods: A single-centre equipment comparison study was conducted. Simultaneous measurements were obtained in 220 patients with both a Contec CMS50D Fingertip Pulse Oximeter and a Nihon Kohden Life Scope MU-631 RK conventional bedside monitor. Peripheral oxygen saturations (SpO₂) and pulse rates were documented, and patient skin tone was recorded using the Fitzpatrick scale. Data was assessed using a Bland-Altman analysis with bias, precision and limits of agreement (LOA) calculated with 95% confidence intervals. A priori acceptability for LOA was determined to be 3%, in keeping with international standards. Results: Mean difference (therefore bias) between the conventional and fingertip oximeters for all data was -0,55% (95% CI -0,73 to -0,36%). Upper and lower limits of agreement (95% CI) were 2,16 (1,84 to 2,47) and -3,25 (-3,56 to -2,94) %. Regression analysis demonstrated worsening agreement with decreasing SpO₂. When samples were separated into “normal” (SpO₂ ≥ 93%) and “hypoxaemic” (SpO₂ < 93%) groups, the normal range displayed acceptable agreement between the two oximeters (bias -0,20 with LOA 2,20 to -2,27%), while the hypoxaemic group fell outside the study’s a priori limits. Heart rate measurements had mean difference (LOA) of -0,43 (-5,61 to 4,76) beats per minute. The study was not powered to detect difference among the skin tones, but demonstrated no trend for this parameter to alter the SpO₂ measurements. Conclusions: During normoxia, portable fingertip pulse oximeters are reliable indicators of SpO₂ and pulse rates in patients with various comorbidities in a pragmatic clinical context. However, they display worsening agreement with conventional pulse oximeters during hypoxaemia. Skin tones do not appear to adversely affect measurements. 2019-02-19T13:31:05Z 2019-02-19T13:31:05Z 2018 2019-02-19T10:53:25Z Master Thesis Masters MMed http://hdl.handle.net/11427/29680 eng application/pdf Department of Anaesthesia and Perioperative Medicine Faculty of Health Sciences University of Cape Town |
| spellingShingle | Anaesthesiology Smith, Reuben Nathanael Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) |
| thesis_degree_str | Master's |
| title | Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) |
| title_full | Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) |
| title_fullStr | Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) |
| title_full_unstemmed | Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) |
| title_short | Perioperative comparison of the agreement between a portable fingertip pulse oximeter vs. a conventional bedside pulse oximeter in adult patients (COMFORT trial) |
| title_sort | perioperative comparison of the agreement between a portable fingertip pulse oximeter vs a conventional bedside pulse oximeter in adult patients comfort trial |
| topic | Anaesthesiology |
| url | http://hdl.handle.net/11427/29680 |
| work_keys_str_mv | AT smithreubennathanael perioperativecomparisonoftheagreementbetweenaportablefingertippulseoximetervsaconventionalbedsidepulseoximeterinadultpatientscomforttrial |