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Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
BACKGROUND:Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Endotracheal tube size ,airway manipulation ,patients position et al. have been recognized as the factors affecting Postoperative Sore Throat .Controversy in respect of the relationship between the cuff design and POST is still existed. Whether the new type of ETT (TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.
METHODS:Patients undergoing elective non-throat and non-neck surgery were randomly allocated to receive either a TaperGuard ETT(group T) or Cylindrical-shaped ETT ( Group C).Patients received general anesthesia with different endotracheal tubes .Recoil of inflation syringe plunger was used to inflate the cuff. In the study , the cuff pressures of the endotracheal tube were recorded by a calibrated cuff manometer at two time: when the intubation was complited and before endotracheal tube was removed. The incidence and severity of Postoperative Sore Throat(POST),hoarseness, cough were collected by a single investigator blinded to the experiment at 0, 1,6, 12, and 24 hours post-operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TaperGuard ETT | Experimental | tracheal intubation with the TaperGuard ETT,the ETT cuff is Taper-shangped. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TaperGuard ETT | Other | tracheal intubation with TaperGuard ETT |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative | 0,1,,6,12,24 hours post-operative | |
| The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative | 0,1,,6,12,24 hours post-operative |
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Inclusion Criteria:
aged 18 to 75 years
ASA classⅠ or Ⅱ
undergoing elective non-throat and non-neck surgery under generalanesthesia
intubation timemore than two hours
BMI≤30 kg/m2
Exclusion Criteria:
known airway disease and difficult intubation
more than one attempt at intubation
Mallampati grade 3 to 4
Cormack-Lehane grade3 to 4
BMI >35 Kg/m2
Those have an operation with the lateral flank or prone position
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao zhao Yang, MD,PhD | Contact | 0866-17709873399 | 0866 | 524798465@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Z Yang, MD,PhD | The Second Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116000 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2016 | |
| Unrelease | Yes | |
| Release | Feb 4, 2016 | |
| Reset | Mar 3, 2016 | |
| Release | Apr 5, 2016 | |
| Reset | May 10, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2016 | Yes | |||
| Feb 4, 2016 |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mar 3, 2016 |
| Apr 5, 2016 | May 10, 2016 |