Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capnography | Experimental | Capnographic respiration monitoring |
|
| Pulse-Oxymetry | Active Comparator | pulse-oxymetric respiration monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcap (Oridion, Needham, MA, USA) | Device |
| ||
| Smart Capno Line Plus O2 (Oridion, Needham, MA, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia (SO2 <90%) | Study objective is to evaluate if a reduction of hypoxic events (SO2 <90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Hypoxia (SO2 <85%) | Evaluate events of severe hypoxia (SO2 < 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring) | |
| Time to hypoxia | Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mireen Friedrich-Rust, MD | Klinikum der J. W. Goethe-Universität Frankfurt am Main | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der J. W. Goethe-Universität | Frankfurt am Main | 60590 | Germany | |||
| Praxisklinik am Staedel |
Not provided
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| Hypoxia in relation to sedation | Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation. |
| Vegetative Symptoms | Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms |
| Frankfurt am Main |
| 60596 |
| Germany |