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This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.
Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Combination rapid sequence intubation (RSI) with use of rocuronium and the bag-mask ventilation between induction and Gum Elastic Bougie GEB will be systematically used at the first attempt to facilitate intubation. |
|
| Control Group | Active Comparator | Physicians will be reminded of the current recommendations for emergency intubation: Rapid sequence intubation (RSI) using succinylcholine and use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data patient | Other | Medical History and characteristic of patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe intubation-related complications occurring during the first hour after intubation | Proportion of patients with severe intubation-related complications occurring during the first hour after intubation The severe intubation-related complications are:
| Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty of the intubation process - Intubation Difficulty | Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements. | Day 0 |
| Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier COMBES, Pr | Contact | 05 56 79 49 47 | 033 | xavier.combes@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier COMBES, Pr | Université Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Recruiting | Angers | 49933 | France |
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| Physical examination | Other | Arterial pressure, arterial oxygen saturation, heart rate |
|
| Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB | Procedure | Rapid sequence intubation (RSI) will be performed with use of rocuronium as paralytic agent (1.2 mg/ kg). Bag-mask ventilation between induction and laryngoscopy will be performed. The GEB will be systematically used at the first attempt to facilitate intubation. |
|
| Rapid sequence intubation (RSI) : Recommendations for emergency intubation | Procedure | Rapid sequence intubation (RSI) using succinylcholine as a paralytic agent (1 mg/kg), no systematic bag-mask ventilation between induction and laryngoscopy, use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy. |
|
Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable |
| Day 0 |
| Difficulty of the intubation process - Alternative techniques. | Proportion of patients intubated by alternative techniques. | Day 0 |
| Difficulty of the intubation process - Intubation attempts | Mean number of intubation attempts | Day 0 |
| Difficulty of the intubation process - Intubation failures under direct laryngoscopy. | Mean number of intubation failures under direct laryngoscopy. | Day 0 |
| Out-of hospital care -Time of out-of-hospital care | Mean time of out-of-hospital care (in minutes) | Day 0 |
| Out-of hospital care - sedative drugs | Mean total amount of sedative drugs used after intubation | Day 0 |
| Out-of hospital care - vasopressors | Mean total amount of vasopressors used after intubation | Day 0 |
| Out-of hospital care : Mortality | Out-of-hospital mortality. | Day 0 |
| Mortality | Vital status | Day 28 |
| CH Carnelle Portes de l'Oise | Recruiting | Beaumont-sur-Oise | 95260 | France |
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| AP-HP - Hôpital Avicenne | Recruiting | Bobigny | 93000 | France |
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| CHU de Bordeaux - Hôpital Pellegrin | Recruiting | Bordeaux | 33000 | France |
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| CH de Pontoise René Dubos | Recruiting | Cergy-Pontoise | 95303 | France |
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| AP-HP - Hôpital Henri Mondor | Recruiting | Créteil | 94000 | France |
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| CHU de Dijon | Not yet recruiting | Dijon | 21000 | France |
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| GH Eaubonne Montmorency Hôpital Simone VEIL | Recruiting | Eaubonne | 95600 | France |
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| AP-HP - Hôpital Raymond Poincaré | Recruiting | Garches | 92380 | France |
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| CHU de Grenoble - Hôpital Nord La Tronche | Recruiting | La Tronche | 38700 | France |
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| CH de Versailles - Site André Mignot | Not yet recruiting | Le Chesnay | 78157 | France |
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| HCL - Hôpital Edouard Herriot | Recruiting | Lyon | 69003 | France |
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| GH Sud Ile de France | Recruiting | Melun | 77000 | France |
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| CHU de Montpellier Site Lapeyronie | Recruiting | Montpellier | 34000 | France |
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| CHU de Nantes - Hôpital Hôtel Dieu | Recruiting | Nantes | 44093 | France |
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| AP-HP - Hôpital Lariboisière | Recruiting | Paris | 75013 | France |
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| AP-HP - Hôpital Pitié-Salpétrière | Recruiting | Paris | 75013 | France |
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| AP-HP - Hôpital Necker | Recruiting | Paris | 75730 | France |
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| CHU Poitiers - Hôpital la Milétrie | Recruiting | Poitiers | 86021 | France |
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| CHU de la Réunion - site Sud | Recruiting | Saint-Pierre | 97448 | France |
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| GH Sélestat Obernai | Not yet recruiting | Sélestat | 67 600 | France |
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| CHU Toulouse - Hôpital Purpan | Recruiting | Toulouse | 31059 | France |
|
| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D000079603 | Rapid Sequence Induction and Intubation |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D007440 | Intubation |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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