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Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.
SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-I | Active Comparator | Tracheal intubation using I-gel and ventilating bougie insertion. In Group-I, following general anaesthesia I-gel is to be inserted, through it ventilating bougie is to be inserted then I-gel is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed. |
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| Group-C | Active Comparator | Tracheal intubation using C-LMA and ventilating bougie insertion. In Group-C, following general anaesthesia C-LMA is to be inserted, through it ventilating bougie is to be inserted then C-LMA is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracheal Intubation using I-gel and ventilating bougie | Device | Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts for I-gel or Classic-LMA Insertions | 60 seconds | |
| Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 45 seconds | |
| Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 30 seconds | |
| Time of Insertion | 5 minutes | |
| Total Intubation Time | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate to observe at the following time intervals.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditi A Dhimar, M.D.(anaes) | CDSCO | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25197106 | Background | Kapoor S, Jethava DD, Gupta P, Jethava D, Kumar A. Comparison of supraglottic devices i-gel((R)) and LMA Fastrach((R)) as conduit for endotracheal intubation. Indian J Anaesth. 2014 Jul;58(4):397-402. doi: 10.4103/0019-5049.138969. | |
| 22653838 | Result | Wong DT, Yang JJ, Mak HY, Jagannathan N. Use of intubation introducers through a supraglottic airway to facilitate tracheal intubation: a brief review. Can J Anaesth. 2012 Jul;59(7):704-15. doi: 10.1007/s12630-012-9714-8. Epub 2012 Jun 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group-I | In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie. Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tracheal Intubation using C-LMA and ventilating bougie | Device | Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube. |
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| 25 minutes |
| Systolic Blood Pressure | Systolic blood pressure measured at following time intervals.
| 25 minutes |
| Diastolic Blood Pressure | Diastolic blood pressure measured at following time intervals.
| 25 minutes |
| 23087456 | Result | Singh J, Yadav MK, Marahatta SB, Shrestha BL. Randomized crossover comparison of the laryngeal mask airway classic with i-gel laryngeal mask airway in the management of difficult airway in post burn neck contracture patients. Indian J Anaesth. 2012 Jul;56(4):348-52. doi: 10.4103/0019-5049.100815. |
| FG001 | Group-C | In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie. Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group-I | In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie. Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube. |
| BG001 | Group-C | In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie. Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| ASAPS ( American society of Anaesthesiologist's physical ststus | ASA I: A normal healthy patient Healthy, non-smoking, no or minimal alcohol use ASA II: A patient with mild systemic disease Mild diseases only without substantive functional limitations. ASA III: A patient with severe systemic disease Substantive functional limitations; One or more moderate to severe diseases. ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | Number | participants |
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| BMI (body mass index) | Mean | Standard Deviation | Kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Attempts for I-gel or Classic-LMA Insertions | Posted | Number | attempt | 60 seconds |
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| Primary | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | Posted | Number | attempt | 45 seconds |
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| Primary | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | Posted | Number | attempt | 30 seconds |
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| Secondary | Heart Rate | Heart rate to observe at the following time intervals.
| Posted | Mean | Standard Deviation | beats per minute | 25 minutes |
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| Secondary | Systolic Blood Pressure | Systolic blood pressure measured at following time intervals.
| Posted | Mean | Standard Deviation | mmhg | 25 minutes |
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| Secondary | Diastolic Blood Pressure | Diastolic blood pressure measured at following time intervals.
| Posted | Mean | Standard Deviation | mmhg | 25 minutes |
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| Primary | Time of Insertion | Posted | Mean | Standard Deviation | Seconds | 5 minutes |
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| Primary | Total Intubation Time | Posted | Mean | Standard Deviation | Second | 5 minutes |
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24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group-I | In Group-I, I-gel is to be used as a conduit for tracheal intubation using ventilating bougie. Tracheal Intubation: Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube. | 0 | 29 | 2 | 29 | ||
| EG001 | Group-C | In Group-C, C-LMA is to be used as a conduit for tracheal intubation using ventilating bougie. Tracheal Intubation: Following general anaesthesia C-LMA was inserted. Aftre proper placement ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube. | 0 | 29 | 4 | 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Airway trauma | Surgical and medical procedures | Non-systematic Assessment | Trauma to tongue, lips, teeth, pharyngeal tissue etc. |
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| Tube impingement | Surgical and medical procedures | Non-systematic Assessment |
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The use of fiber optic bronchoscope for confirmation of proper placement of I-gel and C-LMA would have been better. Also One can see the passage of ventilating bougie through I-gel and C-LMA into larynx and trachea.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Aditi Amrutlal Dhimar | Medical College, Baroda. | 09825334605 | dhimaraditi@yahoo.in |
| >=65 years |
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| Male |
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| ASAPS II |
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| 3rd attempt |
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