Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2.
In critically ill patients, endotracheal intubation (ETI) is lifesaving but carries a high risk of adverse events, notably hypoxemia. Preoxygenation is performed before introducing the tube to increase the safe apnea time. Oxygenation is monitored by pulse oximeter measurement of peripheral oxygen s...
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Public Library of Science (PLoS)
2024-01-01
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| Online Access: | https://doi.org/10.1371/journal.pone.0307723 |
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| author | Hugo Hille Aurélie Le Thuaut Pierre Asfar Quentin Quelven Emmanuelle Mercier Anthony Le Meur Jean-Pierre Quenot Virginie Lemiale Grégoire Muller Martin Cour Alexis Ferré Asael Berge Anaïs Curtiaud Maxime Touron Gaetan Plantefeve Jean-Charles Chakarian Jean-Damien Ricard Gwenhael Colin Arthur Orieux Patrick Girardie Mathieu Jozwiak Manon Rouaud Camille Juhel Jean Reignier Jean-Baptiste Lascarrou CRICS-TRIGGERSEP Network |
| author_facet | Hugo Hille Aurélie Le Thuaut Pierre Asfar Quentin Quelven Emmanuelle Mercier Anthony Le Meur Jean-Pierre Quenot Virginie Lemiale Grégoire Muller Martin Cour Alexis Ferré Asael Berge Anaïs Curtiaud Maxime Touron Gaetan Plantefeve Jean-Charles Chakarian Jean-Damien Ricard Gwenhael Colin Arthur Orieux Patrick Girardie Mathieu Jozwiak Manon Rouaud Camille Juhel Jean Reignier Jean-Baptiste Lascarrou CRICS-TRIGGERSEP Network |
| author_sort | Hugo Hille |
| collection | DOAJ |
| description | In critically ill patients, endotracheal intubation (ETI) is lifesaving but carries a high risk of adverse events, notably hypoxemia. Preoxygenation is performed before introducing the tube to increase the safe apnea time. Oxygenation is monitored by pulse oximeter measurement of peripheral oxygen saturation (SpO2). However, SpO2 is unreliable at the high oxygenation levels produced by preoxygenation and, in the event of desaturation, may not decrease sufficiently early to allow preventive measures. The oxygen reserve index (ORI) is a dimensionless parameter that can also be measured continuously by a fingertip monitor and reflects oxygenation in the moderate hyperoxia range. The ORI ranges from 0 to 1 when arterial oxygen saturation (PaO2) varies between 100 to 200 mmHg, as occurs during preoxygenation. No trial has assessed the potential effects of ORI monitoring to guide preoxygenation for ETI in unstable patients. We designed a multicenter, two-arm, parallel-group, randomized, superiority, open trial in 950 critically ill adults requiring ETI. The intervention consists in monitoring ORI values and using an ORI target for preoxygenation of at least 0.6 for at least 1 minute. In the control group, preoxygenation is guided by SpO2 values recorded by a standard pulse oximeter, according to the standard of care, the goal being to obtain 100% SpO2 during preoxygenation, which lasts at least 3 minutes. The standard-of-care ETI technique is used in both arms. Baseline parameters, rapid-sequence induction medications, ETI devices, and physiological data are recorded. The primary outcome is the lowest SpO2 value from laryngoscopy to 2 minutes after successful ETI. Secondary outcomes include cognitive function on day 28. Assuming a 10% standard deviation for the lowest SpO2 value in the control group, no missing data, and crossover of 5% of patients, with the bilateral alpha risk set at 0.05, including 950 patients will provide 85% power for detecting a 2% between-group absolute difference in the lowest SpO2 value. Should ORI monitoring with a target of ≥0.6 be found to increase the lowest SpO2 value during ETI, then this trial may change current practice regarding preoxygenation for ETI. Trial registration: Registered on ClinicalTrials.gov (NCT05867875) on April 27, 2023. |
| format | Article |
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| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS ONE |
| spelling | doaj-art-1d3956cd0754487f83fbdf11ee8dd4e92025-01-29T05:30:46ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01199e030772310.1371/journal.pone.0307723Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2.Hugo HilleAurélie Le ThuautPierre AsfarQuentin QuelvenEmmanuelle MercierAnthony Le MeurJean-Pierre QuenotVirginie LemialeGrégoire MullerMartin CourAlexis FerréAsael BergeAnaïs CurtiaudMaxime TouronGaetan PlantefeveJean-Charles ChakarianJean-Damien RicardGwenhael ColinArthur OrieuxPatrick GirardieMathieu JozwiakManon RouaudCamille JuhelJean ReignierJean-Baptiste LascarrouCRICS-TRIGGERSEP NetworkIn critically ill patients, endotracheal intubation (ETI) is lifesaving but carries a high risk of adverse events, notably hypoxemia. Preoxygenation is performed before introducing the tube to increase the safe apnea time. Oxygenation is monitored by pulse oximeter measurement of peripheral oxygen saturation (SpO2). However, SpO2 is unreliable at the high oxygenation levels produced by preoxygenation and, in the event of desaturation, may not decrease sufficiently early to allow preventive measures. The oxygen reserve index (ORI) is a dimensionless parameter that can also be measured continuously by a fingertip monitor and reflects oxygenation in the moderate hyperoxia range. The ORI ranges from 0 to 1 when arterial oxygen saturation (PaO2) varies between 100 to 200 mmHg, as occurs during preoxygenation. No trial has assessed the potential effects of ORI monitoring to guide preoxygenation for ETI in unstable patients. We designed a multicenter, two-arm, parallel-group, randomized, superiority, open trial in 950 critically ill adults requiring ETI. The intervention consists in monitoring ORI values and using an ORI target for preoxygenation of at least 0.6 for at least 1 minute. In the control group, preoxygenation is guided by SpO2 values recorded by a standard pulse oximeter, according to the standard of care, the goal being to obtain 100% SpO2 during preoxygenation, which lasts at least 3 minutes. The standard-of-care ETI technique is used in both arms. Baseline parameters, rapid-sequence induction medications, ETI devices, and physiological data are recorded. The primary outcome is the lowest SpO2 value from laryngoscopy to 2 minutes after successful ETI. Secondary outcomes include cognitive function on day 28. Assuming a 10% standard deviation for the lowest SpO2 value in the control group, no missing data, and crossover of 5% of patients, with the bilateral alpha risk set at 0.05, including 950 patients will provide 85% power for detecting a 2% between-group absolute difference in the lowest SpO2 value. Should ORI monitoring with a target of ≥0.6 be found to increase the lowest SpO2 value during ETI, then this trial may change current practice regarding preoxygenation for ETI. Trial registration: Registered on ClinicalTrials.gov (NCT05867875) on April 27, 2023.https://doi.org/10.1371/journal.pone.0307723 |
| spellingShingle | Hugo Hille Aurélie Le Thuaut Pierre Asfar Quentin Quelven Emmanuelle Mercier Anthony Le Meur Jean-Pierre Quenot Virginie Lemiale Grégoire Muller Martin Cour Alexis Ferré Asael Berge Anaïs Curtiaud Maxime Touron Gaetan Plantefeve Jean-Charles Chakarian Jean-Damien Ricard Gwenhael Colin Arthur Orieux Patrick Girardie Mathieu Jozwiak Manon Rouaud Camille Juhel Jean Reignier Jean-Baptiste Lascarrou CRICS-TRIGGERSEP Network Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. PLoS ONE |
| title | Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. |
| title_full | Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. |
| title_fullStr | Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. |
| title_full_unstemmed | Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. |
| title_short | Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. |
| title_sort | impact of non invasive oxygen reserve index versus standard spo2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit protocol for the randomized controlled trial nesoi2 |
| url | https://doi.org/10.1371/journal.pone.0307723 |
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