Clinical trial NCT06288724 - References

Critical Illness — MOdifiable facTors to Improve VentilAtion ThErapy in ICU

Citation(s)

•   Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD
  Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11.
•   African COVID-19 Critical Care Outcomes Study (ACCCOS) Investigators
  Patient care and clinical outcomes for patients with COVID-19 infection admitted to African high-care or intensive care units (ACCCOS): a multicentre, prospective, observational cohort study. Lancet. 2021 May 22;397(10288):1885-1894. doi: 10.1016/S0140-6736(21)00441-4. Erratum In: Lancet. 2021 Jun 26;397(10293):2466.
•   Alali AS, Scales DC, Fowler RA, Mainprize TG, Ray JG, Kiss A, de Mestral C, Nathens AB
  Tracheostomy timing in traumatic brain injury: a propensity-matched cohort study. J Trauma Acute Care Surg. 2014 Jan;76(1):70-6; discussion 76-8. doi: 10.1097/TA.0b013e3182a8fd6a.
•   Andrews B, Semler MW, Muchemwa L, Kelly P, Lakhi S, Heimburger DC, Mabula C, Bwalya M, Bernard GR
  Effect of an Early Resuscitation Protocol on In-hospital Mortality Among Adults With Sepsis and Hypotension: A Randomized Clinical Trial. JAMA. 2017 Oct 3;318(13):1233-1240. doi: 10.1001/jama.2017.10913.
•   Arabi YM, Dabbagh OC, Tamim HM, Al-Shimemeri AA, Memish ZA, Haddad SH, Syed SJ, Giridhar HR, Rishu AH, Al-Daker MO, Kahoul SH, Britts RJ, Sakkijha MH
  Intensive versus conventional insulin therapy: a randomized controlled trial in medical and surgical critically ill patients. Crit Care Med. 2008 Dec;36(12):3190-7. doi: 10.1097/CCM.0b013e31818f21aa.
•   Aryal D, Beane A, Dondorp AM, Green C, Haniffa R, Hashmi M, Jayakumar D, Marshall JC, McArthur CJ, Murthy S, Webb SA, Acharya SP, Ishani PGP, Jawad I, Khanal S, Koirala K, Luitel S, Pabasara U, Paneru HR, Kumar A, Patel SS, Ramakrishnan N, Salahuddin N, Shaikh M, Tolppa T, Udayanga I, Umrani Z
  Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system. Wellcome Open Res. 2021 Jan 28;6:14. doi: 10.12688/wellcomeopenres.16486.1. eCollection 2021.
•   Atumanya P, Sendagire C, Wabule A, Mukisa J, Ssemogerere L, Kwizera A, Agaba PK
  Assessment of the current capacity of intensive care units in Uganda; A descriptive study. J Crit Care. 2020 Feb;55:95-99. doi: 10.1016/j.jcrc.2019.10.019. Epub 2019 Nov 4.
•   Barr J, Ghaferi AA, Costa DK, Hedlin HK, Ding VY, Ross C, Pun BT, Watson SR, Asch SM
  Organizational Characteristics Associated With ICU Liberation (ABCDEF) Bundle Implementation by Adult ICUs in Michigan. Crit Care Explor. 2020 Aug 19;2(8):e0169. doi: 10.1097/CCE.0000000000000169. eCollection 2020 Aug.
•   Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group
  Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
•   Chorath K, Hoang A, Rajasekaran K, Moreira A
  Association of Early vs Late Tracheostomy Placement With Pneumonia and Ventilator Days in Critically Ill Patients: A Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):450-459. doi: 10.1001/jamaoto.2021.0025.
•   Cuschieri S
  The STROBE guidelines. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S31-S34. doi: 10.4103/sja.SJA_543_18.
•   Dijkema LM, Dieperink W, van Meurs M, Zijlstra JG
  Preventable mortality evaluation in the ICU. Crit Care. 2012 Dec 12;16(2):309. doi: 10.1186/cc11212.
•   Donabedian A
  Evaluating the quality of medical care. 1966. Milbank Q. 2005;83(4):691-729. doi: 10.1111/j.1468-0009.2005.00397.x. No abstract available.
•   Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group
  Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
•   GBD 2015 Healthcare Access and Quality Collaborators
  Electronic address: cjlm@uw.edu; GBD 2015 Healthcare Access and Quality Collaborators. Healthcare Access and Quality Index based on mortality from causes amenable to personal health care in 195 countries and territories, 1990-2015: a novel analysis from the Global Burden of Disease Study 2015. Lancet. 2017 Jul 15;390(10091):231-266. doi: 10.1016/S0140-6736(17)30818-8. Epub 2017 May 18.
•   Goligher EC, Ferguson ND, Brochard LJ
  Clinical challenges in mechanical ventilation. Lancet. 2016 Apr 30;387(10030):1856-66. doi: 10.1016/S0140-6736(16)30176-3. Epub 2016 Apr 28.
•   Haniffa R, De Silva AP, Iddagoda S, Batawalage H, De Silva ST, Mahipala PG, Dondorp A, de Keizer N, Jayasinghe S
  A cross-sectional survey of critical care services in Sri Lanka: a lower middle-income country. J Crit Care. 2014 Oct;29(5):764-8. doi: 10.1016/j.jcrc.2014.04.021. Epub 2014 May 9.
•   Inglis R, Ayebale E, Schultz MJ
  Optimizing respiratory management in resource-limited settings. Curr Opin Crit Care. 2019 Feb;25(1):45-53. doi: 10.1097/MCC.0000000000000568.
•   Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL
  Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. Erratum In: Clin Infect Dis. 2017 May 1;64(9):1298. Clin Infect Dis. 2017 Oct 15;65(8):1435. Clin Infect Dis. 2017 Nov 29;65(12):2161.
•   Karthikeyan B, Kadhiravan T, Deepanjali S, Swaminathan RP
  Case-Mix, Care Processes, and Outcomes in Medically-Ill Patients Receiving Mechanical Ventilation in a Low-Resource Setting from Southern India: A Prospective Clinical Case Series. PLoS One. 2015 Aug 11;10(8):e0135336. doi: 10.1371/journal.pone.0135336. eCollection 2015.
•   Kerlin MP, Adhikari NK, Rose L, Wilcox ME, Bellamy CJ, Costa DK, Gershengorn HB, Halpern SD, Kahn JM, Lane-Fall MB, Wallace DJ, Weiss CH, Wunsch H, Cooke CR; ATS Ad Hoc Committee on ICU Organization
  An Official American Thoracic Society Systematic Review: The Effect of Nighttime Intensivist Staffing on Mortality and Length of Stay among Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Feb 1;195(3):383-393. doi: 10.1164/rccm.201611-2250ST.
•   Khatib KI, Dixit SB, Joshi MM
  Factors determining outcomes in adult patient undergoing mechanical ventilation: A "real-world" retrospective study in an Indian Intensive Care Unit. Int J Crit Illn Inj Sci. 2018 Jan-Mar;8(1):9-16. doi: 10.4103/IJCIIS.IJCIIS_41_17.
•   Kwizera A, Dunser M, Nakibuuka J
  National intensive care unit bed capacity and ICU patient characteristics in a low income country. BMC Res Notes. 2012 Sep 1;5:475. doi: 10.1186/1756-0500-5-475.
•   Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, Brochard L, Clarkson K, Esteban A, Gattinoni L, van Haren F, Heunks LM, Kurahashi K, Laake JH, Larsson A, McAuley DF, McNamee L, Nin N, Qiu H, Ranieri M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators and the ESICM Trials Group
  Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2016 Dec;42(12):1865-1876. doi: 10.1007/s00134-016-4571-5. Epub 2016 Oct 18. Erratum In: Intensive Care Med. 2017 Nov 14;:
•   Laffey JG, Madotto F, Bellani G, Pham T, Fan E, Brochard L, Amin P, Arabi Y, Bajwa EK, Bruhn A, Cerny V, Clarkson K, Heunks L, Kurahashi K, Laake JH, Lorente JA, McNamee L, Nin N, Palo JE, Piquilloud L, Qiu H, Jimenez JIS, Esteban A, McAuley DF, van Haren F, Ranieri M, Rubenfeld G, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group
  Geo-economic variations in epidemiology, patterns of care, and outcomes in patients with acute respiratory distress syndrome: insights from the LUNG SAFE prospective cohort study. Lancet Respir Med. 2017 Aug;5(8):627-638. doi: 10.1016/S2213-2600(17)30213-8. Epub 2017 Jun 15.
•   Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group
  Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26.
•   Mendsaikhan N, Begzjav T, Lundeg G, Dunser MW
  Potentially Preventable Deaths by Intensive Care Medicine in Mongolian Hospitals. Crit Care Res Pract. 2016;2016:8624035. doi: 10.1155/2016/8624035. Epub 2016 Oct 4.
•   Mulima G, Lie SA, Charles A, Hanif AB, Varela CG, Banza LN, Young S
  Tracheostomy without mechanical ventilation in patients with traumatic brain injury at a tertiary referral hospital in Malawi: a cross sectional study. Malawi Med J. 2022 Sep;34(3):152-156. doi: 10.4314/mmj.v34i3.2.
•   Murthy S, Leligdowicz A, Adhikari NK
  Intensive care unit capacity in low-income countries: a systematic review. PLoS One. 2015 Jan 24;10(1):e0116949. doi: 10.1371/journal.pone.0116949. eCollection 2015.
•   Neto AS, Barbas CSV, Simonis FD, Artigas-Raventos A, Canet J, Determann RM, Anstey J, Hedenstierna G, Hemmes SNT, Hermans G, Hiesmayr M, Hollmann MW, Jaber S, Martin-Loeches I, Mills GH, Pearse RM, Putensen C, Schmid W, Severgnini P, Smith R, Treschan TA, Tschernko EM, Melo MFV, Wrigge H, de Abreu MG, Pelosi P, Schultz MJ; PRoVENT; PROVE Network investigators
  Epidemiological characteristics, practice of ventilation, and clinical outcome in patients at risk of acute respiratory distress syndrome in intensive care units from 16 countries (PRoVENT): an international, multicentre, prospective study. Lancet Respir Med. 2016 Nov;4(11):882-893. doi: 10.1016/S2213-2600(16)30305-8. Epub 2016 Oct 4.
•   Parker RK, Mwachiro EB, Mwachiro MM, Pletcher J, Parker AS, Many HR
  Mortality Prediction in Rural Kenya: A Cohort Study of Mechanical Ventilation in Critically Ill Patients. Crit Care Explor. 2019 Dec 10;1(12):e0067. doi: 10.1097/CCE.0000000000000067. eCollection 2019 Dec.
•   Phua J, Faruq MO, Kulkarni AP, Redjeki IS, Detleuxay K, Mendsaikhan N, Sann KK, Shrestha BR, Hashmi M, Palo JEM, Haniffa R, Wang C, Hashemian SMR, Konkayev A, Mat Nor MB, Patjanasoontorn B, Nafees KMK, Ling L, Nishimura M, Al Bahrani MJ, Arabi YM, Lim CM, Fang WF; Asian Analysis of Bed Capacity in Critical Care (ABC) Study Investigators, and the Asian Critical Care Clinical Trials Group
  Critical Care Bed Capacity in Asian Countries and Regions. Crit Care Med. 2020 May;48(5):654-662. doi: 10.1097/CCM.0000000000004222.
•   Pisani L, Algera AG, Neto AS, Azevedo L, Pham T, Paulus F, de Abreu MG, Pelosi P, Dondorp AM, Bellani G, Laffey JG, Schultz MJ; ERICC study investigators; LUNG SAFE study investigators; PRoVENT study investigators; PRoVENT-iMiC study investigators
  Geoeconomic variations in epidemiology, ventilation management, and outcomes in invasively ventilated intensive care unit patients without acute respiratory distress syndrome: a pooled analysis of four observational studies. Lancet Glob Health. 2022 Feb;10(2):e227-e235. doi: 10.1016/S2214-109X(21)00485-X. Epub 2021 Dec 13.
•   Pisani L, Waweru-Siika W, Sendagire C, Beane A, Haniffa R
  Critically ill COVID-19 patients in Africa: it is time for quality registry data. Lancet. 2021 Aug 7;398(10299):485-486. doi: 10.1016/S0140-6736(21)01549-X. No abstract available.
•   Potter JE, McKinley S, Delaney A
  Research participants' opinions of delayed consent for a randomised controlled trial of glucose control in intensive care. Intensive Care Med. 2013 Mar;39(3):472-80. doi: 10.1007/s00134-012-2732-8. Epub 2012 Oct 25.
•   Prin M, Itaye T, Clark S, Fernando RJ, Namboya F, Pollach G, Mkandawire N, Sobol J
  Critical Care in a Tertiary Hospital in Malawi. World J Surg. 2016 Nov;40(11):2635-2642. doi: 10.1007/s00268-016-3578-y.
•   Prin M, Kaizer A, Cardenas J, Mtalimanja O, Kadyaudzu C, Charles A, Ginde A
  Tracheostomy Practices for Mechanically Ventilated Patients in Malawi. World J Surg. 2021 Sep;45(9):2638-2642. doi: 10.1007/s00268-021-06176-3. Epub 2021 Jun 2.
•   Pun BT, Balas MC, Barnes-Daly MA, Thompson JL, Aldrich JM, Barr J, Byrum D, Carson SS, Devlin JW, Engel HJ, Esbrook CL, Hargett KD, Harmon L, Hielsberg C, Jackson JC, Kelly TL, Kumar V, Millner L, Morse A, Perme CS, Posa PJ, Puntillo KA, Schweickert WD, Stollings JL, Tan A, D'Agostino McGowan L, Ely EW
  Caring for Critically Ill Patients with the ABCDEF Bundle: Results of the ICU Liberation Collaborative in Over 15,000 Adults. Crit Care Med. 2019 Jan;47(1):3-14. doi: 10.1097/CCM.0000000000003482.
•   Queen Elizabeth Hospital Birmingham COVID-19 airway team
  Safety and 30-day outcomes of tracheostomy for COVID-19: a prospective observational cohort study. Br J Anaesth. 2020 Dec;125(6):872-879. doi: 10.1016/j.bja.2020.08.023. Epub 2020 Aug 28.
•   Renard Triche L, Futier E, De Carvalho M, Pinol-Domenech N, Bodet-Contentin L, Jabaudon M, Pereira B
  Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review. Crit Care. 2023 Aug 1;27(1):303. doi: 10.1186/s13054-023-04562-y.
•   Riviello ED, Letchford S, Achieng L, Newton MW
  Critical care in resource-poor settings: lessons learned and future directions. Crit Care Med. 2011 Apr;39(4):860-7. doi: 10.1097/CCM.0b013e318206d6d5.
•   Sendagire C, Lipnick MS, Kizito S, Kruisselbrink R, Obua D, Ejoku J, Ssemogerere L, Nakibuuka J, Kwizera A
  Feasibility of the modified sequential organ function assessment score in a resource-constrained setting: a prospective observational study. BMC Anesthesiol. 2017 Jan 26;17(1):12. doi: 10.1186/s12871-017-0304-8.
•   Simonis FD, Barbas CSV, Artigas-Raventos A, Canet J, Determann RM, Anstey J, Hedenstierna G, Hemmes SNT, Hermans G, Hiesmayr M, Hollmann MW, Jaber S, Martin-Loeches I, Mills GH, Pearse RM, Putensen C, Schmid W, Severgnini P, Smith R, Treschan TA, Tschernko EM, Vidal Melo MF, Wrigge H, de Abreu MG, Pelosi P, Schultz MJ, Neto AS; PRoVENT investigators; PROVE Network investigators
  Potentially modifiable respiratory variables contributing to outcome in ICU patients without ARDS: a secondary analysis of PRoVENT. Ann Intensive Care. 2018 Mar 21;8(1):39. doi: 10.1186/s13613-018-0385-7.
•   Soares M, Bozza FA, Angus DC, Japiassu AM, Viana WN, Costa R, Brauer L, Mazza BF, Correa TD, Nunes AL, Lisboa T, Colombari F, Maciel AT, Azevedo LC, Damasceno M, Fernandes HS, Cavalcanti AB, do Brasil PE, Kahn JM, Salluh JI
  Organizational characteristics, outcomes, and resource use in 78 Brazilian intensive care units: the ORCHESTRA study. Intensive Care Med. 2015 Dec;41(12):2149-60. doi: 10.1007/s00134-015-4076-7.
•   Towey RM, Ojara S
  Intensive care in the developing world. Anaesthesia. 2007 Dec;62 Suppl 1:32-7. doi: 10.1111/j.1365-2044.2007.05295.x.
•   Ttendo SS, Was A, Preston MA, Munyarugero E, Kerry VB, Firth PG
  Retrospective Descriptive Study of an Intensive Care Unit at a Ugandan Regional Referral Hospital. World J Surg. 2016 Dec;40(12):2847-2856. doi: 10.1007/s00268-016-3644-5.
•   Vijayaraghavan BKT, Venkatraman R, Ramakrishnan N
  Critical Care Registries: The Next Big Stride? Indian J Crit Care Med. 2019 Aug;23(8):387. doi: 10.5005/jp-journals-10071-23227.
•   Vukoja M, Riviello E, Gavrilovic S, Adhikari NK, Kashyap R, Bhagwanjee S, Gajic O, Kilickaya O; CERTAIN Investigators
  A survey on critical care resources and practices in low- and middle-income countries. Glob Heart. 2014 Sep;9(3):337-42.e1-5. doi: 10.1016/j.gheart.2014.08.002. Epub 2014 Oct 31.
•   Weled BJ, Adzhigirey LA, Hodgman TM, Brilli RJ, Spevetz A, Kline AM, Montgomery VL, Puri N, Tisherman SA, Vespa PM, Pronovost PJ, Rainey TG, Patterson AJ, Wheeler DS; Task Force on Models for Critical Care
  Critical Care Delivery: The Importance of Process of Care and ICU Structure to Improved Outcomes: An Update From the American College of Critical Care Medicine Task Force on Models of Critical Care. Crit Care Med. 2015 Jul;43(7):1520-5. doi: 10.1097/CCM.0000000000000978.
•   Zampieri FG, Salluh JIF, Azevedo LCP, Kahn JM, Damiani LP, Borges LP, Viana WN, Costa R, Correa TD, Araya DES, Maia MO, Ferez MA, Carvalho AGR, Knibel MF, Melo UO, Santino MS, Lisboa T, Caser EB, Besen BAMP, Bozza FA, Angus DC, Soares M; ORCHESTRA Study Investigators
  ICU staffing feature phenotypes and their relationship with patients' outcomes: an unsupervised machine learning analysis. Intensive Care Med. 2019 Nov;45(11):1599-1607. doi: 10.1007/s00134-019-05790-z. Epub 2019 Oct 8.

Potentially MOdifiable Factors To ImproVe Outcomes of Mechanically Ventilated Patients in ICUs in a Low-income Country: Rationale and Protocol for a Registry-embedded Prospective Observational Study

Details for clinical trial NCT06288724