Extracorporeal Carbon Dioxide Removal to Avoid Invasive Ventilation During Exacerbations of Chronic Obstructive Pulmonary Disease : VENT-AVOID Trial - A Randomized Clinical Trial
Rationale: It is unclear whether extracorporeal CO2 removal (ECCO2R) can reduce the rate of intubation or the total time on invasive mechanical ventilation (IMV) in adults experiencing an exacerbation of chronic obstructive pulmonary disease (COPD). Objectives: To determine whether ECCO2R increases the number of ventilator-free days within the first 5 days postrandomization (VFD-5) in exacerbation of COPD in patients who are either failing noninvasive ventilation (NIV) or who are failing to wean from IMV. Methods: This randomized clinical trial was conducted in 41 U.S. institutions (2018-2022) (ClinicalTrials.gov ID: NCT03255057). Subjects were randomized to receive either standard care with venovenous ECCO2R (NIV stratum: n = 26; IMV stratum: n = 32) or standard care alone (NIV stratum: n = 22; IMV stratum: n = 33). Measurements and Main Results: The trial was stopped early because of slow enrollment and enrolled 113 subjects of the planned sample size of 180. There was no significant difference in the median VFD-5 between the arms controlled by strata (P = 0.36). In the NIV stratum, the median VFD-5 for both arms was 5 days (median shift = 0.0; 95% confidence interval [CI]: 0.0-0.0). In the IMV stratum, the median VFD-5 in the standard care and ECCO2R arms were 0.25 and 2 days, respectively; median shift = 0.00 (95% confidence interval: 0.00-1.25). In the NIV stratum, all-cause in-hospital mortality was significantly higher in the ECCO2R arm (22% vs. 0%, P = 0.02) with no difference in the IMV stratum (17% vs. 15%, P = 0.73). Conclusions: In subjects with exacerbation of COPD, the use of ECCO2R compared with standard care did not improve VFD-5. Clinical trial registered with www.clinicaltrials.gov (NCT03255057).
| Errataetall: |
CommentIn: Am J Respir Crit Care Med. 2024 Mar 1;209(5):472-473. - PMID 38285549 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:209 |
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| Enthalten in: |
American journal of respiratory and critical care medicine - 209(2024), 5 vom: 01. März, Seite 529-542 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Duggal, Abhijit [VerfasserIn] |
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| Links: |
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| Themen: |
142M471B3J |
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| Anmerkungen: |
Date Completed 04.03.2024 Date Revised 04.03.2024 published: Print ClinicalTrials.gov: NCT03255057 CommentIn: Am J Respir Crit Care Med. 2024 Mar 1;209(5):472-473. - PMID 38285549 Citation Status MEDLINE |
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| doi: |
10.1164/rccm.202311-2060OC |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367521164 |
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| 245 | 1 | 0 | |a Extracorporeal Carbon Dioxide Removal to Avoid Invasive Ventilation During Exacerbations of Chronic Obstructive Pulmonary Disease |b VENT-AVOID Trial - A Randomized Clinical Trial |
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| 500 | |a ClinicalTrials.gov: NCT03255057 | ||
| 500 | |a CommentIn: Am J Respir Crit Care Med. 2024 Mar 1;209(5):472-473. - PMID 38285549 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Rationale: It is unclear whether extracorporeal CO2 removal (ECCO2R) can reduce the rate of intubation or the total time on invasive mechanical ventilation (IMV) in adults experiencing an exacerbation of chronic obstructive pulmonary disease (COPD). Objectives: To determine whether ECCO2R increases the number of ventilator-free days within the first 5 days postrandomization (VFD-5) in exacerbation of COPD in patients who are either failing noninvasive ventilation (NIV) or who are failing to wean from IMV. Methods: This randomized clinical trial was conducted in 41 U.S. institutions (2018-2022) (ClinicalTrials.gov ID: NCT03255057). Subjects were randomized to receive either standard care with venovenous ECCO2R (NIV stratum: n = 26; IMV stratum: n = 32) or standard care alone (NIV stratum: n = 22; IMV stratum: n = 33). Measurements and Main Results: The trial was stopped early because of slow enrollment and enrolled 113 subjects of the planned sample size of 180. There was no significant difference in the median VFD-5 between the arms controlled by strata (P = 0.36). In the NIV stratum, the median VFD-5 for both arms was 5 days (median shift = 0.0; 95% confidence interval [CI]: 0.0-0.0). In the IMV stratum, the median VFD-5 in the standard care and ECCO2R arms were 0.25 and 2 days, respectively; median shift = 0.00 (95% confidence interval: 0.00-1.25). In the NIV stratum, all-cause in-hospital mortality was significantly higher in the ECCO2R arm (22% vs. 0%, P = 0.02) with no difference in the IMV stratum (17% vs. 15%, P = 0.73). Conclusions: In subjects with exacerbation of COPD, the use of ECCO2R compared with standard care did not improve VFD-5. Clinical trial registered with www.clinicaltrials.gov (NCT03255057) | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a ECCO2R | |
| 650 | 4 | |a mechanical ventilation | |
| 650 | 7 | |a Carbon Dioxide |2 NLM | |
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| 700 | 1 | |a Conrad, Steven A |e verfasserin |4 aut | |
| 700 | 1 | |a Barrett, Nicholas A |e verfasserin |4 aut | |
| 700 | 1 | |a Saad, Mohamed |e verfasserin |4 aut | |
| 700 | 1 | |a Cheema, Tariq |e verfasserin |4 aut | |
| 700 | 1 | |a Pannu, Sonal |e verfasserin |4 aut | |
| 700 | 1 | |a Romero, Ramiro Saavedra |e verfasserin |4 aut | |
| 700 | 1 | |a Brochard, Laurent |e verfasserin |4 aut | |
| 700 | 1 | |a Nava, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Ranieri, V Marco |e verfasserin |4 aut | |
| 700 | 1 | |a May, Alexandra |e verfasserin |4 aut | |
| 700 | 1 | |a Brodie, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Hill, Nicholas S |e verfasserin |4 aut | |
| 700 | 0 | |a VENT-AVOID Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Dumont, Tiffany |e investigator |4 oth | |
| 700 | 1 | |a Krishnan, Sudhir |e investigator |4 oth | |
| 700 | 1 | |a Exline, Matthew |e investigator |4 oth | |
| 700 | 1 | |a Paz, Francisco |e investigator |4 oth | |
| 700 | 1 | |a Huelster, Joshua |e investigator |4 oth | |
| 700 | 1 | |a Medarov, Boris |e investigator |4 oth | |
| 700 | 1 | |a Sanchez, Juan |e investigator |4 oth | |
| 700 | 1 | |a Benninghoff, Michael |e investigator |4 oth | |
| 700 | 1 | |a Barrett, Matthew |e investigator |4 oth | |
| 700 | 1 | |a Douglas, Ivor |e investigator |4 oth | |
| 700 | 1 | |a Mansoori, Jason |e investigator |4 oth | |
| 700 | 1 | |a Rackley, Craig |e investigator |4 oth | |
| 700 | 1 | |a MacIntyre, Neil |e investigator |4 oth | |
| 700 | 1 | |a Bermudez, Christian |e investigator |4 oth | |
| 700 | 1 | |a Schweickert, William |e investigator |4 oth | |
| 700 | 1 | |a King, Christopher |e investigator |4 oth | |
| 700 | 1 | |a Desai, Mehul |e investigator |4 oth | |
| 700 | 1 | |a Rovella, Jennifer |e investigator |4 oth | |
| 700 | 1 | |a Pechulis, Rita |e investigator |4 oth | |
| 700 | 1 | |a Keith Scott, L |e investigator |4 oth | |
| 700 | 1 | |a Muthiah, Muthiah P |e investigator |4 oth | |
| 700 | 1 | |a Agerstrand, Cara |e investigator |4 oth | |
| 700 | 1 | |a Abrams, Darryl |e investigator |4 oth | |
| 700 | 1 | |a Serra, Alexis |e investigator |4 oth | |
| 700 | 1 | |a Narasimham, Mangala |e investigator |4 oth | |
| 700 | 1 | |a Gottesman, Eric |e investigator |4 oth | |
| 700 | 1 | |a Levy, Mitchell |e investigator |4 oth | |
| 700 | 1 | |a Hussain, Sabiha |e investigator |4 oth | |
| 700 | 1 | |a Jagpal, Sugeet |e investigator |4 oth | |
| 700 | 1 | |a Tamae-Kakazu, Maximiliano |e investigator |4 oth | |
| 700 | 1 | |a Fitch, Stephen |e investigator |4 oth | |
| 700 | 1 | |a Criner, Gerald J |e investigator |4 oth | |
| 700 | 1 | |a Desai, Parag |e investigator |4 oth | |
| 700 | 1 | |a Faugno, Anthony |e investigator |4 oth | |
| 700 | 1 | |a Morrissey, Brian M |e investigator |4 oth | |
| 700 | 1 | |a Albertson, Timothy E |e investigator |4 oth | |
| 700 | 1 | |a Rackauskas, Mindaugas |e investigator |4 oth | |
| 700 | 1 | |a Doerschug, Kevin |e investigator |4 oth | |
| 700 | 1 | |a Sethi, Jigme |e investigator |4 oth | |
| 700 | 1 | |a Enfield, Kyle |e investigator |4 oth | |
| 700 | 1 | |a Kadl, Alexandra |e investigator |4 oth | |
| 700 | 1 | |a Akkanti, Bindu |e investigator |4 oth | |
| 700 | 1 | |a Dinh, Kha |e investigator |4 oth | |
| 700 | 1 | |a Saberi, Asif |e investigator |4 oth | |
| 700 | 1 | |a Mehta, Ashish |e investigator |4 oth | |
| 700 | 1 | |a Seethala, Raghu |e investigator |4 oth | |
| 700 | 1 | |a Blum, James |e investigator |4 oth | |
| 700 | 1 | |a Williams, Mark |e investigator |4 oth | |
| 700 | 1 | |a Buch, Ketan |e investigator |4 oth | |
| 700 | 1 | |a Pham, Si |e investigator |4 oth | |
| 700 | 1 | |a Walter, James |e investigator |4 oth | |
| 700 | 1 | |a Tillis, William |e investigator |4 oth | |
| 700 | 1 | |a Balk, Robert |e investigator |4 oth | |
| 700 | 1 | |a Jamkhana, Zafar |e investigator |4 oth | |
| 700 | 1 | |a Kaul, Pratibha |e investigator |4 oth | |
| 700 | 1 | |a Hite, Duncan |e investigator |4 oth | |
| 700 | 1 | |a Abu-Hijleh, Muhanned |e investigator |4 oth | |
| 700 | 1 | |a Siddiqui, Faisal |e investigator |4 oth | |
| 700 | 1 | |a Dill, Tracey |e investigator |4 oth | |
| 700 | 1 | |a Kinoshita, Yuki |e investigator |4 oth | |
| 700 | 1 | |a Lund, Laura |e investigator |4 oth | |
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