High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context
Summary: Background: Difficult airway management remains a critical procedure with life-threatening adverse events. Current guidelines suggest high-flow therapy by nasal cannulae (HFNC) as a preoxygenation device in this setting. However, there is an evidence gap to support this recommendation. Met...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S258953702300175X |
| _version_ | 1797822047333646336 |
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| author | Mickael Vourc'h Donatien Huard Marguerite Le Penndu Romain Deransy Marielle Surbled Maelle Malidin Pierre-Joachim Mahe Christophe Guitton Antoine Roquilly Olivier Malard Fanny Feuillet Bertrand Rozec Karim Asehnoune |
| author_facet | Mickael Vourc'h Donatien Huard Marguerite Le Penndu Romain Deransy Marielle Surbled Maelle Malidin Pierre-Joachim Mahe Christophe Guitton Antoine Roquilly Olivier Malard Fanny Feuillet Bertrand Rozec Karim Asehnoune |
| author_sort | Mickael Vourc'h |
| collection | DOAJ |
| description | Summary: Background: Difficult airway management remains a critical procedure with life-threatening adverse events. Current guidelines suggest high-flow therapy by nasal cannulae (HFNC) as a preoxygenation device in this setting. However, there is an evidence gap to support this recommendation. Methods: The PREOPTI-DAM study is an open-label, single-centre, randomised controlled phase 3 trial done at Nantes University Hospital, France. Patients were aged 18–90 years with one major or two minor criteria of anticipated difficult airway management, and requiring intubation for scheduled surgery, were eligible. Patients with body mass index >35 kg/m2 were excluded. Patients were randomly allocated (1:1) to receive 4-min preoxygenation by HFNC or facemask. Randomisation was stratified according to the intubation strategy (laryngoscopic versus fiberoptic intubation). The primary outcome was the incidence of oxygen desaturation ≤94% or of bag-mask ventilation during intubation. The primary and safety analyses included the intention to treat population. This trial is registered with ClinicalTrials.gov (NCT03604120) and EudraCT (2018-A00434-51). Findings: From September 4 2018 to March 31 2021, 186 patients were enrolled and randomly assigned. One participant withdrew consent and 185 (99.5%) were included in the primary analysis (HFNC, N = 95; Facemask, N = 90). The incidence of the primary outcome was not significantly different between the HFNC and the facemask groups, respectively 2 (2%) versus 7 (8%); adjusted difference, −5.6 [95% confidence interval (CI), −11.8 to 0.6], P = 0.10. In the HFNC group, 76 patients (80%) versus 53 (59%) in the facemask group, reported good or excellent intubation experiences; adjusted difference 20.5 [95% CI, 8.3–32.8], P = 0.016. Comparing HFNC with facemask, severe complication occurred in 22 (23%) versus 27 (30%) patients (P = 0.29), and moderate complication in 14 (15%) versus 18 (20%) patients (P = 0.35). No death or cardiac arrest occurred during the study. Interpretation: Compared with facemask, HFNC did not significantly reduce the incidence of desaturation ≤94% or bag-mask ventilation during anticipated difficult intubation but the trial was underpowered to rule out a clinically significant benefit. Patient satisfaction was improved with HFNC. Funding: Nantes University Hospital and Fisher & Paykel Healthcare. |
| first_indexed | 2024-03-13T10:03:05Z |
| format | Article |
| id | doaj.art-504aacea015a4d9e909791d68c3058a1 |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-03-13T10:03:05Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-504aacea015a4d9e909791d68c3058a12023-05-23T04:21:58ZengElsevierEClinicalMedicine2589-53702023-06-0160101998High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in contextMickael Vourc'h0Donatien Huard1Marguerite Le Penndu2Romain Deransy3Marielle Surbled4Maelle Malidin5Pierre-Joachim Mahe6Christophe Guitton7Antoine Roquilly8Olivier Malard9Fanny Feuillet10Bertrand Rozec11Karim Asehnoune12Service d’Anesthésie Réanimation Chirurgie Cardiaque, Hôpital Laennec, CHU de Nantes, France; INSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceService de Médecine Intensive Réanimation, Centre Hospitalier du Mans, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, FranceService de Chirurgie Oto-Rhino-Laryngologique (ORL) et Chirurgie Cervico-faciale, Hôtel Dieu, CHU de Nantes, FranceINSERM, Methods in Patient-Centered Outcomes and Health Research, SPHERE, CHU de Tours, France; Service de Pharmacie, Hôtel Dieu, CHU de Nantes, France; Plateforme de Méthodologie et de Biostatistique, DRI CHU de Nantes, FranceService d’Anesthésie Réanimation Chirurgie Cardiaque, Hôpital Laennec, CHU de Nantes, France; Institut du Thorax, Institut National de la Santé et de la Recherche Médicale (INSERM), Centre National de la Recherche Scientifique (CNRS), Université de Nantes, FranceINSERM CIC 0004 Immunologie et Infectiologie, Université de Nantes, France; Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, CHU de Nantes, France; Corresponding author. Department of Anaesthesiology and Critical Care, Hôtel-Dieu, University Hospital of Nantes, 44093, Nantes, France.Summary: Background: Difficult airway management remains a critical procedure with life-threatening adverse events. Current guidelines suggest high-flow therapy by nasal cannulae (HFNC) as a preoxygenation device in this setting. However, there is an evidence gap to support this recommendation. Methods: The PREOPTI-DAM study is an open-label, single-centre, randomised controlled phase 3 trial done at Nantes University Hospital, France. Patients were aged 18–90 years with one major or two minor criteria of anticipated difficult airway management, and requiring intubation for scheduled surgery, were eligible. Patients with body mass index >35 kg/m2 were excluded. Patients were randomly allocated (1:1) to receive 4-min preoxygenation by HFNC or facemask. Randomisation was stratified according to the intubation strategy (laryngoscopic versus fiberoptic intubation). The primary outcome was the incidence of oxygen desaturation ≤94% or of bag-mask ventilation during intubation. The primary and safety analyses included the intention to treat population. This trial is registered with ClinicalTrials.gov (NCT03604120) and EudraCT (2018-A00434-51). Findings: From September 4 2018 to March 31 2021, 186 patients were enrolled and randomly assigned. One participant withdrew consent and 185 (99.5%) were included in the primary analysis (HFNC, N = 95; Facemask, N = 90). The incidence of the primary outcome was not significantly different between the HFNC and the facemask groups, respectively 2 (2%) versus 7 (8%); adjusted difference, −5.6 [95% confidence interval (CI), −11.8 to 0.6], P = 0.10. In the HFNC group, 76 patients (80%) versus 53 (59%) in the facemask group, reported good or excellent intubation experiences; adjusted difference 20.5 [95% CI, 8.3–32.8], P = 0.016. Comparing HFNC with facemask, severe complication occurred in 22 (23%) versus 27 (30%) patients (P = 0.29), and moderate complication in 14 (15%) versus 18 (20%) patients (P = 0.35). No death or cardiac arrest occurred during the study. Interpretation: Compared with facemask, HFNC did not significantly reduce the incidence of desaturation ≤94% or bag-mask ventilation during anticipated difficult intubation but the trial was underpowered to rule out a clinically significant benefit. Patient satisfaction was improved with HFNC. Funding: Nantes University Hospital and Fisher & Paykel Healthcare.http://www.sciencedirect.com/science/article/pii/S258953702300175XPreoxygenationHigh-flow oxygen therapyIntubationFiberoptic intubationApnoeic oxygenationDifficult intubation |
| spellingShingle | Mickael Vourc'h Donatien Huard Marguerite Le Penndu Romain Deransy Marielle Surbled Maelle Malidin Pierre-Joachim Mahe Christophe Guitton Antoine Roquilly Olivier Malard Fanny Feuillet Bertrand Rozec Karim Asehnoune High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context EClinicalMedicine Preoxygenation High-flow oxygen therapy Intubation Fiberoptic intubation Apnoeic oxygenation Difficult intubation |
| title | High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context |
| title_full | High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context |
| title_fullStr | High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context |
| title_full_unstemmed | High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context |
| title_short | High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trialResearch in context |
| title_sort | high flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management preopti dam an open label single centre randomised controlled phase 3 trialresearch in context |
| topic | Preoxygenation High-flow oxygen therapy Intubation Fiberoptic intubation Apnoeic oxygenation Difficult intubation |
| url | http://www.sciencedirect.com/science/article/pii/S258953702300175X |
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