High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial
Abstract Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with...
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| Format: | Article |
| Language: | English |
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BMC
2020-12-01
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| Series: | Critical Care |
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| Online Access: | https://doi.org/10.1186/s13054-020-03409-0 |
| _version_ | 1818844649130819584 |
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| author | Andrea Cortegiani Federico Longhini Fabiana Madotto Paolo Groff Raffaele Scala Claudia Crimi Annalisa Carlucci Andrea Bruni Eugenio Garofalo Santi Maurizio Raineri Roberto Tonelli Vittoria Comellini Enrico Lupia Luigi Vetrugno Enrico Clini Antonino Giarratano Stefano Nava Paolo Navalesi Cesare Gregoretti the H. F.-AECOPD study investigators |
| author_facet | Andrea Cortegiani Federico Longhini Fabiana Madotto Paolo Groff Raffaele Scala Claudia Crimi Annalisa Carlucci Andrea Bruni Eugenio Garofalo Santi Maurizio Raineri Roberto Tonelli Vittoria Comellini Enrico Lupia Luigi Vetrugno Enrico Clini Antonino Giarratano Stefano Nava Paolo Navalesi Cesare Gregoretti the H. F.-AECOPD study investigators |
| author_sort | Andrea Cortegiani |
| collection | DOAJ |
| description | Abstract Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. Results Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were − 6.8 mmHg (± 8.7) in the HFNT and − 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. Conclusions HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. Trial registration: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666). |
| first_indexed | 2024-12-19T05:17:07Z |
| format | Article |
| id | doaj.art-7f83fde483024e24b57a56a2d0690c5e |
| institution | Directory Open Access Journal |
| issn | 1364-8535 |
| language | English |
| last_indexed | 2024-12-19T05:17:07Z |
| publishDate | 2020-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Critical Care |
| spelling | doaj.art-7f83fde483024e24b57a56a2d0690c5e2022-12-21T20:34:37ZengBMCCritical Care1364-85352020-12-0124111310.1186/s13054-020-03409-0High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trialAndrea Cortegiani0Federico Longhini1Fabiana Madotto2Paolo Groff3Raffaele Scala4Claudia Crimi5Annalisa Carlucci6Andrea Bruni7Eugenio Garofalo8Santi Maurizio Raineri9Roberto Tonelli10Vittoria Comellini11Enrico Lupia12Luigi Vetrugno13Enrico Clini14Antonino Giarratano15Stefano Nava16Paolo Navalesi17Cesare Gregoretti18the H. F.-AECOPD study investigatorsDepartment of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of PalermoIntensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia UniversityValue-Based Healthcare Unit, IRCCS MultiMedicaEmergency Department, “S. Maria Della Misericordia” HospitalPulmonology and Respiratory Intensive Care Unit, S. Donato HospitalRespiratory Medicine Unit, A.O.U. “Policlinico-Vittorio Emanuele”Pulmonary Rehabilitation Unit, Department of Medicina E Chirurgia, Istituti Clinici Scientifici Maugeri, Università Insubria VareseIntensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia UniversityIntensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia UniversityDepartment of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of PalermoClinical and Experimental Medicine PhD Program, University of Modena and Reggio EmiliaDepartment of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital, Alma Mater UniversityUnit of Emergency Medicine, Department of Medical Sciences, University of TurinDepartment of Medicine, Clinic of Anesthesia and Intensive Care, University of UdineRespiratory Diseases Unit, Department of Medical and Surgical Sciences SMECHIMAI, University Hospital of Modena Policlinico, University of Modena Reggio EmiliaDepartment of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of PalermoDepartment of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital, Alma Mater UniversitySection of Anesthesiology and Intensive Care, Department of Medicine - DIMED, University of PadovaDepartment of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of PalermoAbstract Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. Results Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were − 6.8 mmHg (± 8.7) in the HFNT and − 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. Conclusions HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. Trial registration: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).https://doi.org/10.1186/s13054-020-03409-0High flow nasal therapyHigh flow nasal cannulaNoninvasive ventilationChronic obstructive pulmonary diseaseAcute respiratory failure |
| spellingShingle | Andrea Cortegiani Federico Longhini Fabiana Madotto Paolo Groff Raffaele Scala Claudia Crimi Annalisa Carlucci Andrea Bruni Eugenio Garofalo Santi Maurizio Raineri Roberto Tonelli Vittoria Comellini Enrico Lupia Luigi Vetrugno Enrico Clini Antonino Giarratano Stefano Nava Paolo Navalesi Cesare Gregoretti the H. F.-AECOPD study investigators High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial Critical Care High flow nasal therapy High flow nasal cannula Noninvasive ventilation Chronic obstructive pulmonary disease Acute respiratory failure |
| title | High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial |
| title_full | High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial |
| title_fullStr | High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial |
| title_full_unstemmed | High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial |
| title_short | High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial |
| title_sort | high flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in copd exacerbation a multicenter non inferiority randomized trial |
| topic | High flow nasal therapy High flow nasal cannula Noninvasive ventilation Chronic obstructive pulmonary disease Acute respiratory failure |
| url | https://doi.org/10.1186/s13054-020-03409-0 |
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