Evaluation of the effect of oral caffeine in helping to liberate (Liberation) from the ventilator in intubated and mechanically ventilated patients admitted to the intensive care unit

Evaluation of the effect of oral caffeine in helping to liberate from the ventilator in intubated and mechanically ventilated patients admitted to the intensive care unit

Clinical trial with control group, with parallel groups, double-blind, randomized with the help of Excel statistical software, phase 3 on 124 patients

This study is performed in Imam Hossein Hospital, Tehran, Iran. Patients admitted to the General ICU who, according to the Intensive Care Specialist, is more than 48 hours dependent on a ventilator will be randomly divided into two groups. In the intervention group, caffeine tablets with a dose of 200 mg twice daily through the gastric tube, and in the control group, the corresponding placebo is received with the same dose. After recording the cause of hospitalization and APACHE score, patients are visited daily in terms of the possibility of separation from the device, and in case of appropriate clinical conditions, the device mode is changed to spontaneous and RSBI is calculated and weaning decision is made based on it. The duration of the need for mechanical ventilation, the need for re-intubation, the duration of hospitalization in the ICU, and the duration of hospitalization will be recorded. The drug and placebo are also labeled in packages and the patient and caregiver are kept blind.

Inclusion criteria: all intubated patients in the General ICU who are expected to be ventilators for more than 48 hours. Exclusion criteria: myopathy, ischemic heart problems, and cardiac arrhythmias, neurosurgery patients, caffeine sensitivity.

In the intervention group, caffeine tablets with a dose of 200 mg twice daily through the gastric tube and in the control group, the corresponding placebo is received with the same dose.

Duration of mechanical ventilation

With simple randomization and using a random number table and individual randomization unit. To randomize, we use a table consisting of random digits 0 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each number is assigned to a treatment group. We start from the first line of the table and move down line by line. For the two treatments, we put the numbers 0 to 4 for treatment A and the numbers 5 to 9 for treatment B. The numbers in the first line of the table are as follows: 0,5,2,7,8,4,3,7,4,1,6,8,3,8,5,1,5,6,9,6, ... Now for people based on the above numbers, we have the following allocation: A, B, A, B, B,. We will continue the above process until the two groups are completed.

In this two-way blind study, the hub group is assigned by the physician using statistical software and the drug and placebo are provided to the clinical caregiver in a labeled form. In order to prevent any problems, information about the drugs is provided only to the principal investigator.