NCT03678532 - 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)

Kress JP, Vinayak AG, Levitt J, Schweickert WD, Gehlbach BK, Zimmerman F, Pohlman AS, Hall JB
Daily sedative interruption in mechanically ventilated patients at risk for coronary artery disease. Crit Care Med. 2007 Feb;35(2):365-71.
Laerkner E, Stroem T, Toft P
No-sedation during mechanical ventilation: impact on patient's consciousness, nursing workload and costs. Nurs Crit Care. 2016 Jan;21(1):28-35. doi: 10.1111/nicc.12161. Epub 2015 Apr 17.
Strøm T, Toft P
Sedation and analgesia in mechanical ventilation. Semin Respir Crit Care Med. 2014 Aug;35(4):441-50. doi: 10.1055/s-0034-1382156. Epub 2014 Aug 11.
Toft P, Olsen HT, Jørgensen HK, Strøm T, Nibro HL, Oxlund J, Wian KA, Ytrebø LM, Kroken BA, Chew M
Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial. Trials. 2014 Dec 20;15:499. doi: 10.1186/1745-6215-15-499.

Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients

Clinical trial NCT03678532 - References