NCT05370248 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brochard L, Slutsky A, Pesenti A
Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S
Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
Mehta AB, Syeda SN, Wiener RS, Walkey AJ
Epidemiological trends in invasive mechanical ventilation in the United States: A population-based study. J Crit Care. 2015 Dec;30(6):1217-21. doi: 10.1016/j.jcrc.2015.07.007. Epub 2015 Jul 16.
Moxham J, Goldstone J
Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61.
Petrof BJ
Diaphragm Weakness in the Critically Ill: Basic Mechanisms Reveal Therapeutic Opportunities. Chest. 2018 Dec;154(6):1395-1403. doi: 10.1016/j.chest.2018.08.1028. Epub 2018 Aug 23. Review.
Supinski GS, Morris PE, Dhar S, Callahan LA
Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5. Review.
Tremblay LN, Slutsky AS
Ventilator-induced lung injury: from the bench to the bedside. Intensive Care Med. 2006 Jan;32(1):24-33. Epub 2005 Oct 18. Review.
Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A
Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12. Review.

The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial

Details for clinical trial NCT05370248

Clinical trial NCT05370248 - References