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| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capnographic monitoring group | Experimental | In this group, in addition to the standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients, the capnographic is also monitored. The capnographic data of the patients are available for additional noninvasive assessment of ventilation. |
|
| Standard monitoring group | Active Comparator | In this group, standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients. Capnographic data are not visible by closing the CO2 sampling line till the endoscopy end. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnography monitoring | Device | Standard monitoring and capnographic monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoxia | (75% ≤ SpO2 < 90% for <60 s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sub-clinical respiratory depression | (90% ≤ SpO2 < 95%) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The incidence of severe hypoxia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diansan Su, Dr. | Department of Anesthesiology Renji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhenzhou | Henan | 450003 | China | ||
| Qilu Hospital of Shandong University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36918924 | Derived | Lian Q, Chen S, Cheng X, Zhang J, Yu W, Zhou R, Su D. Capnographic monitoring reduces hypoxia incidence in older patients undergoing gastrointestinal endoscopy under propofol sedation: study protocol for a multicenter randomized controlled trial. Trials. 2023 Mar 15;24(1):192. doi: 10.1186/s13063-023-07208-0. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D013274 | Stomach Neoplasms |
| C562464 | Polyposis, Gastric |
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
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| Standard monitoring | Device | Standard monitoring but no capnographic monitoring |
|
(SpO2 < 75% or 75% ≤ SpO2 < 90% for >/=60 s)
| Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia | capnography curve decreased by half or more than the baseline and even disappeared, SpO2 >90% | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Qingdao |
| Shandong |
| 250012 |
| China |
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |