NCT05805293 - 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)

Chawla R, Dixit SB, Zirpe KG, Chaudhry D, Khilnani GC, Mehta Y, Khatib KI, Jagiasi BG, Chanchalani G, Mishra RC, Samavedam S, Govil D, Gupta S, Prayag S, Ramasubban S, Dobariya J, Marwah V, Sehgal I, Jog SA, Kulkarni AP
ISCCM Guidelines for the Use of Non-invasive Ventilation in Acute Respiratory Failure in Adult ICUs. Indian J Crit Care Med. 2020 Jan;24(Suppl 1):S61-S81. doi: 10.5005/jp-journals-10071-G23186.
Fernandez Alvarez R, Belda Ramirez J, Rubinos Cuadrado G, Buchelli Ramirez H, Fole Vazquez D, Iscar Urrutia M, Rodriguez Jerez F, Vazquez Lopez MJ, Casan Clara P
Obesity-Hypoventilation Syndrome: Baseline Hemodynamic Status and Impact of non-Invasive Ventilation. Arch Bronconeumol (Engl Ed). 2020 Jul;56(7):441-445. doi: 10.1016/j.arbres.2019.08.022. Epub 2019 Dec 25. English, Spanish.
Masa JF, Pepin JL, Borel JC, Mokhlesi B, Murphy PB, Sanchez-Quiroga MA
Obesity hypoventilation syndrome. Eur Respir Rev. 2019 Mar 14;28(151):180097. doi: 10.1183/16000617.0097-2018. Print 2019 Mar 31.
Nicolini A, Ferrando M, Solidoro P, Di Marco F, Facchini F, Braido F
Non-invasive ventilation in acute respiratory failure of patients with obesity hypoventilation syndrome. Minerva Med. 2018 Dec;109(6 Suppl 1):1-5. doi: 10.23736/S0026-4806.18.05921-9.

High-Velocity Nasal Insufflation Therapy Versus Non-Invasive Ventilation In Management Of Acute Hypercapnic Respiratory Failure In Obesity Hypoventilation Syndrome: A Randomized Controlled Trial

Details for clinical trial NCT05805293

Clinical trial NCT05805293 - References