Dat, Vu Quoc
Geskus, Ronald B.
Wolbers, Marcel
Loan, Huynh Thi
Yen, Lam Minh
Binh, Nguyen Thien
Chien, Le Thanh
Mai, Nguyen Thi Hoang
Phu, Nguyen Hoan
Lan, Nguyen Phu Huong
Hao, Nguyen Van
Long, Hoang Bao
Thuy, Tran Phuong
Kinh, Nguyen Van
Trung, Nguyen Vu
Phu, Vu Dinh
Cap, Nguyen Trung
Trinh, Dao Tuyet
Campbell, James
Kestelyn, Evelyne
Wertheim, Heiman F. L.
Wyncoll, Duncan
Thwaites, Guy Edward
van Doorn, H. Rogier
Thwaites, C. Louise
Nadjm, Behzad http://orcid.org/0000-0002-7704-3629
Funding for this research was provided by:
Wellcome Trust (Major Overseas Programme (OUCRU) Core Grant)
Article History
Received: 3 August 2017
Accepted: 12 March 2018
First Online: 4 April 2018
Ethics approval and consent to participate
: Ethical approval was obtained through the Oxford Tropical Research Ethics Committee (OxTREC) (reference 26-16), the Tropical Diseases Hospital in Ho Chi Minh City (reference number 32/HDDD), Trung Vuong Emergency Hospital (reference number 670/BVTV) and National Hospital of Tropical Diseases (reference number 22/HDDD-NDTU). The original approved version of this study did not have a 90-day limit on the intervention and follow-up for endpoints; these changes have been approved in amendments. Patients who require intubation at the study site on or after arrival or who have been intubated prior to transfer, or their legal representatives, will be approached as soon as is possible in line with prioritising patient care, fully informed, and invited to consent to the study. Consent will be obtained by study or hospital staff trained in good clinical practice and the consent procedure. Patients will be enrolled only after informed consent has been obtained. Randomisation will then take place, and patients will be managed in the appropriate manner. Patient care will never be delayed for consent or randomisation procedures. Where consent is provided by a patient’s representative and they later regain the capacity to provide consent, the patient will be approached and given the opportunity to withdraw from the study.
: Not applicable.
: DW has served as a board member for Astellas; lectured for HealthCare 21, Astellas, Pfizer, Sage, Johnson & Johnson, and Bioproducts; received support for the development of educational presentations from Astellas; and received funding from Pfizer (board member) and Astellas (board member), as well as Sage, Healthcare21, Johnson & Johnson and Bioproducts speaker bureaus (all unrelated to this work). The other authors declare that they have no competing interests.
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