Question special

The control group had higher rates of weaning failure, infectious complications, multi-organ failure, and death in the the hospital (although some of the difference CIs cross 0). It seems reasonable to interpret these data as showing that capping trials are associated with excess complications, which may be mediators of the prolonged time to decannulation in that group. But this interpretation appears to hinge on whether or not we can actually attribute these complications to the capping trial itself, or the reduction in these complications to the intervention. If not, these complications would seem not to be outcomes so much as evidence that the two groups were not equal—that the control group had higher rates of independent/unrelated complications that account for at least some of the difference in the primary outcome.

I don’t have any clinical experience caring for patients actively being assessed for decannulation and don’t have a good sense of the expected rates of respiratory and infectious complications in these patients. Are the rates in either group surprising—do they seem unusually high in the control group or unusually low in the intervention group?

Did your group have a protocol for assessing whether the secondary outcomes were caused by the capping or suctioning trials themselves?