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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00047-34 | Other Identifier | ID-RCB |
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The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteer subject | Experimental | A single healthy volunteer subject will participate in the study as a model of a pregnant woman in the third trimester of pregnancy, with a functional respiratory capacity reduced by 20% thanks to elastic restraints performed under the control of functional respiratory explorations. 8 obstetric anesthesiologists will participate in the 4 scenarios; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scenario 1 : pre-oxygenation with a face mask held by the anaesthetist | Procedure | the face mask is held by the anaesthetist (reference technique) to obtain effective pre-oxygenation for Oxygen Reserve Index (ORI) which has reached a plateau value for more than 10 seconds. All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation | Difference between the time when volunteer enters the operating room and the time when the conditions for general anaesthesia are met during pre-oxygenation with the face mask applied by one anaesthesist in charge of the volunteer (simulated patient) compared to the use of preoxygenation with THRIVE by one anaesthesist in charge of the volunteer | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| time between volunteer enters the operating room and when the conditions for general anaesthesia are met during pre-oxygenation | Difference between the time when volunteer enters the operating room and the time when the conditions for general anaesthesia are met during pre-oxygenation with the face mask applied by one anaesthetist in charge of the volunteer (simulated patient), during pre-oxygenation with the face mask applied by the volunteer (one anaesthetist in charge of the simulated patient), during preoxygenation with THRIVE (one anaesthetist in charge of the simulated patient), during preoxygenation with the facemask applied by the anaesthetist or the nurse anaesthetist both in charge of the simulated patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Femme Mère Enfant | Bron | 69500 | France |
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| scenario 2: one anaesthetist in charge, face mask held by the patient for pre-oxygenation | Procedure | one anaesthetist is in charge of the simulated patient (volunteer), face mask held by the volunteer for pre-oxygenation for ORI which has reached a plateau value for more than 10 seconds All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows:
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| scenario 3: one anaesthetist in charge, THRIVE used for pre-oxygenation | Procedure | All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows:
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| scenario 4: one anaesthetist and one nurse anaesthetist in charge, the face mask is held by the anaesthetist or the nurse anaesthetist | Procedure | All the usual supplies and medicines are available and in the same place as usual. The sequence is as follows:
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| through study completion, an average of 1 year |
| number of medication errors during the preparation | Medication errors occurring during treatment in the 4 scenarios will be counted (medication preparation errors, no medication is administered to the volunteer) | through study completion, an average of 1 year |
| number of deviations from appropriate anaesthetic practices observed during preparation | The number of deviations from the appropriate anesthetic practices observed during the preparation will be counted in the 4 scenarios | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D005249 | Fees and Charges |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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