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The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.
The study aims to draw a comparison between ProSeal LMA, i-gel and LTS-D supraglottic airway devices in terms of the efficacy and safety in anaesthetised patient on Mechanical ventilation undergoing elective surgical procedure.
Methodology: A prospective randomized control study conducted on 150 patients undergoing elective surgical procedure under general anaesthesia at Dr Sushila Tiwari Hospital and Government medical college, Haldwani.
Following detailed pre-anaesthetic check-up, informed written consent was taken from patient fulfilling the required criteria. Patients were randomly allocated into 3 groups namely Group I (i-gel, n=50), Group P (p-LMA, n=50) and Group L (LTS-D, n=50) by online generated randomization.
Standard general anaesthesia protocol was followed and once adequate depth was achieved i-gel or p-LMA or LTS-D appropriate for weight or / and height was selected and inserted. An effective airway was confirmed and device was fixed from maxilla to maxilla.
The three groups were compared with respect to number of Insertion attempts, ease of insertion of device, time taken for placement of device, airway sealing pressure, ease and number of attempts of gastric tube placement and complications noted if any.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProSeal Laryngeal mask airway | Active Comparator | ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries. |
|
| Laryngeal Tube Suction- Disposable | Active Comparator | LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries. |
|
| Group I | Active Comparator | i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProSeal Laryngeal mask airway | Device | ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Insertion attempts | 10 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Grading of insertion of device by Easy or Difficult | Easy insertion is defined as no resistance to insert in first attempt. Any repeat attempt or resistance to insertion is defined as Difficult. | 10 min |
| Time taken for placement of device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geeta Bhandari, MD | Professor | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 2, 2017 | |
| Reset | Nov 3, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 2, 2017 | Nov 3, 2017 |
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| Laryngeal Tube Suction- Disposable | Device | LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries. |
|
| i-gel | Device | i-gel was inserted in mechanically ventilated patients undergoing elective surgeries. |
|
| 10 min |
| Airway sealing pressure | 10 min |
| Number of attempts of gastric tube placement | 20 min |
| Complication | 120 min |