Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2002DR2266 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ impairment. In order to tolerate this aggressive mechanical support, enhance patient synchrony with the ventilator, and relieve pain and anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of sedation and analgesia may prolong the duration of mechanical ventilation and increase the risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the widespread use of sedation, little information is available concerning the effect of varying the level of sedation on patients' subsequent mental health. We designed a randomized controlled trial to investigate the efficacy of sedation with the goal of maintaining the patient cooperative and interactive compared to the administration of sedation with the goal of maintaining the patient sedated. The first goal will be achieved by a discontinuous injection of a sedative, while the second goal will be achieved by a continuous infusion of the same sedative. In both groups pain relief will be provided in the same fashion with equal endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU stay, as indicated by the time to discharge from the ICU, the time to separation from mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and hospital length of stay. These endpoints will be compared between the two groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam with 2 different levels of sedation scores | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Post-traumatic stress disorders (PTSD) | ||
| Anxiety | ||
| Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge from the Intensive Care Unit | ||
| Time to separation from mechanical ventilation | ||
| Rates of pulmonary and extra-pulmonary complications Hospital length of stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Miriam M Treggiari, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1211 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012140 | Respiratory Tract Diseases |
| D006571 | Heterocyclic Compounds |