Comparison of the clinical outcomes of non-invasive ventilation by helmet vs facemask in patients with acute respiratory distress syndrome
The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expirato...
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Published in | Medicine (Baltimore) Vol. 100; no. 4; p. e24443 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
Lippincott Williams & Wilkins
29.01.2021
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Online Access | Get full text |
ISSN | 0025-7974 1536-5964 1536-5964 |
DOI | 10.1097/MD.0000000000024443 |
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Abstract | The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV.Patients aged more than 18 years old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance.
NCT04507802.
May 2020. |
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AbstractList | The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV.Patients aged more than 18 years old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance.ABSTRACTThe main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV.Patients aged more than 18 years old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance.NCT04507802.TRIAL REGISTRATION NUMBERNCT04507802.May 2020.PROTOCOL VERSIONMay 2020. The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV.Patients aged more than 18 years old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance. NCT04507802. May 2020. The main aim of this study is to compare the use of non-invasive ventilation (NIV) via helmet versus face mask where different interfaces and masks can apply NIV. However, some of the limitations of the NIV face mask were air leak, face mask intolerance, and requirement of high positive end expiratory pressure, which could be resolved with the use of the helmet NIV. NIV facemask will be applied as per the facial contour of the patient. NIV helmet is a transparent hood and size will be measured as per the head size. Both groups will have a standard protocol for titration of NIV. Patients aged more than 18 years old and diagnosed with acute respiratory distress syndrome as per Berlin definition will be enrolled in the study after signing the informed consent. Subjects who met the inclusion criteria will receive 1 of the 2 interventions; blood gases, oxygenation status [Po2/Fio2] will be monitored in both groups. The time of intubation will be the main comparison factor among the 2 groups. The primary and secondary outcomes will be measured by the number of patients requiring endotracheal intubation after application of helmet device, Improvement of oxygenation defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100, duration of mechanical ventilation via an endotracheal tube, intensive care unit length of stay, death from any cause during hospitalization at the time of enrolment, need for proning during the hospital stay, intensive care unit mortality, and the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance. |
Author | Shaik, Karimulla S. Khatib, Mohamad Y. Shahen, Muhsen A. Mohamed, Ahmed S. Elshafei, Moustafa S. Soliman, Ahmed A. Peediyakkal, Mohamed Z. Ananthegowda, Dore C. Kannappilly, Nevin Nashwan, Abdulqadir J. Abdaljawad, Wael I. Elzeer, Hani S. |
AuthorAffiliation | Critical Care Medicine Department, Hazm Mebaireek General Hospital (HMGH), Hamad Medical Corporation (HMC), Doha, Qatar |
AuthorAffiliation_xml | – name: Critical Care Medicine Department, Hazm Mebaireek General Hospital (HMGH), Hamad Medical Corporation (HMC), Doha, Qatar |
Author_xml | – sequence: 1 givenname: Mohamad Y. surname: Khatib fullname: Khatib, Mohamad Y. organization: Critical Care Medicine Department, Hazm Mebaireek General Hospital (HMGH), Hamad Medical Corporation (HMC), Doha, Qatar – sequence: 2 givenname: Mohamed Z. surname: Peediyakkal fullname: Peediyakkal, Mohamed Z. – sequence: 3 givenname: Moustafa S. surname: Elshafei fullname: Elshafei, Moustafa S. – sequence: 4 givenname: Hani S. surname: Elzeer fullname: Elzeer, Hani S. – sequence: 5 givenname: Dore C. surname: Ananthegowda fullname: Ananthegowda, Dore C. – sequence: 6 givenname: Muhsen A. surname: Shahen fullname: Shahen, Muhsen A. – sequence: 7 givenname: Wael I. surname: Abdaljawad fullname: Abdaljawad, Wael I. – sequence: 8 givenname: Karimulla S. surname: Shaik fullname: Shaik, Karimulla S. – sequence: 9 givenname: Nevin surname: Kannappilly fullname: Kannappilly, Nevin – sequence: 10 givenname: Ahmed S. surname: Mohamed fullname: Mohamed, Ahmed S. – sequence: 11 givenname: Ahmed A. surname: Soliman fullname: Soliman, Ahmed A. – sequence: 12 givenname: Abdulqadir J. surname: Nashwan fullname: Nashwan, Abdulqadir J. |
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CitedBy_id | crossref_primary_10_1002_hsr2_525 crossref_primary_10_1002_ccr3_4513 crossref_primary_10_1016_j_bja_2023_12_022 crossref_primary_10_5339_qmj_2023_29 crossref_primary_10_1002_hsr2_339 crossref_primary_10_1186_s13054_021_03746_8 crossref_primary_10_1097_MD_0000000000028637 crossref_primary_10_3389_fmed_2022_874250 |
Cites_doi | 10.1186/cc13103 10.1007/s11739-012-0856-z 10.1001/jama.2016.0291 10.1007/s00134-012-2475-6 10.1097/01.CCM.0000251821.44259.F3 10.1007/s00134-012-2682-1 10.1001/jama.2016.6338 10.2214/ajr.148.3.501 10.4187/respcare.02319 10.1136/bmjopen-2020-040428 10.1097/00003246-200211000-00008 10.1097/00075198-200402000-00001 |
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SubjectTerms | Adolescent Adult Clinical Trials, Phase III as Topic Critical Care Outcomes Female Head Protective Devices Humans Intensive Care Units Length of Stay Male Masks Middle Aged Noninvasive Ventilation - instrumentation Randomized Controlled Trials as Topic Respiratory Distress Syndrome - therapy Study Protocol Clinical Trial Treatment Outcome Young Adult |
Title | Comparison of the clinical outcomes of non-invasive ventilation by helmet vs facemask in patients with acute respiratory distress syndrome |
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