Intubation; Difficult
Conditions
Keywords
C-LMA, I-gel, ventilating bougie, intubation
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* age 18 to 60 years * Gender : either sex * American society of Anaesthesiologist's Physical Status (ASAPS) I and II * Patients posted for surgery requiring general anaesthesia and endotracheal intubation.
Exclusion criteria
* age \<18 years and \> 60 years * ASAPS III or IV * Obesity body mass index \>25 * Patients with mouth opening \<2cms * Patients with Malampatti grade III and IV * Patients having history of gastro-esophageal reflux disease * Patients with history of inadequate fasting * Patients with known or anticipated difficult tracheal intubation or face-mask ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Intubation Time | 5 minutes |
| 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 |
| Number of Attempts for I-gel or Classic-LMA Insertions | 60 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 25 minutes | Systolic blood pressure measured at following time intervals. 1. Base line 2. After Dexmedetomidine injection 3. After induction of anaesthesia 4. Supraglottic airway insertion 5. Ventilating bougie insertion 6. ETT insertion 7. 3 minute after ETT insertion 8. 5 minute after ETT insertion 9. 7 minute after ETT insertion 10. 10 minute after ETT insertion 11. 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends. |
| Diastolic Blood Pressure | 25 minutes | Diastolic blood pressure measured at following time intervals. 1. Base line 2. After Dexmedetomidine injection 3. After Induction 4. Supraglottic airway insertion 5. Ventilating bougie insertion 6. ETT insertion 7. 3 minute after ETT insertion 8. 5 minute after ETT insertion 9. 7 minute after ETT insertion 10. 10 minutes after ETT insertion 11. 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends. |
| Heart Rate | 25 minutes | Heart rate to observe at the following time intervals. 1. Base line 2. After induction 3. After dexmedetomidine injection 4. Supraglottic airway insertion 5. Ventilating bougie insertion 6. ETT insertion 7. 3minute after ETT insertion 8. 5 minute after ETT insertion 9. 7 minute after ETT insertion 10. 10 minute after ETT insertion 11. 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Group-I | Group-C | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Continuous | 35.03 Years STANDARD_DEVIATION 10.13 | 36.13 Years STANDARD_DEVIATION 11.24 | 35.58 Years STANDARD_DEVIATION 10.68 |
| ASAPS ( American society of Anaesthesiologist's physical ststus ASAPS I | 21 participants | 23 participants | 44 participants |
| ASAPS ( American society of Anaesthesiologist's physical ststus ASAPS II | 8 participants | 6 participants | 14 participants |
| BMI (body mass index) | 21.30 Kg/m2 STANDARD_DEVIATION 2.96 | 21.43 Kg/m2 STANDARD_DEVIATION 2.19 | 21.36 Kg/m2 STANDARD_DEVIATION 2.57 |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 29 | 4 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Number of Attempts for I-gel or Classic-LMA Insertions
Time frame: 60 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group-I | Number of Attempts for I-gel or Classic-LMA Insertions | 1st attempt | 25 attempt |
| Group-I | Number of Attempts for I-gel or Classic-LMA Insertions | 2nd attempt | 2 attempt |
| Group-I | Number of Attempts for I-gel or Classic-LMA Insertions | 3rd attempt | 2 attempt |
| Group-C | Number of Attempts for I-gel or Classic-LMA Insertions | 1st attempt | 22 attempt |
| Group-C | Number of Attempts for I-gel or Classic-LMA Insertions | 2nd attempt | 5 attempt |
| Group-C | Number of Attempts for I-gel or Classic-LMA Insertions | 3rd attempt | 2 attempt |
Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
Time frame: 30 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group-I | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 1st attempt | 29 attempt |
| Group-I | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 2nd attempt | 0 attempt |
| Group-I | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 3rd attempt | 0 attempt |
| Group-C | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 1st attempt | 28 attempt |
| Group-C | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 2nd attempt | 1 attempt |
| Group-C | Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie | 3rd attempt | 0 attempt |
Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
Time frame: 45 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group-I | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 1st attempt | 23 attempt |
| Group-I | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 2nd attempt | 6 attempt |
| Group-I | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 3rd attempt | 0 attempt |
| Group-C | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 1st attempt | 24 attempt |
| Group-C | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 2nd attempt | 4 attempt |
| Group-C | Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA | 3rd attempt | 1 attempt |
Time of Insertion
Time frame: 5 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group-I | Time of Insertion | Supraglottic airway | 26.17 Seconds | Standard Deviation 2.25 |
| Group-I | Time of Insertion | Ventilating bougie | 31.51 Seconds | Standard Deviation 8.87 |
| Group-I | Time of Insertion | ETT | 25.58 Seconds | Standard Deviation 4.01 |
| Group-C | Time of Insertion | Supraglottic airway | 44.65 Seconds | Standard Deviation 9.14 |
| Group-C | Time of Insertion | Ventilating bougie | 26.31 Seconds | Standard Deviation 9.25 |
| Group-C | Time of Insertion | ETT | 28.13 Seconds | Standard Deviation 8.31 |
Total Intubation Time
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-I | Total Intubation Time | 93.27 Second | Standard Deviation 9.03 |
| Group-C | Total Intubation Time | 108.96 Second | Standard Deviation 16.5 |
Diastolic Blood Pressure
Diastolic blood pressure measured at following time intervals. 1. Base line 2. After Dexmedetomidine injection 3. After Induction 4. Supraglottic airway insertion 5. Ventilating bougie insertion 6. ETT insertion 7. 3 minute after ETT insertion 8. 5 minute after ETT insertion 9. 7 minute after ETT insertion 10. 10 minutes after ETT insertion 11. 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.
Time frame: 25 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group-I | Diastolic Blood Pressure | ETT insertion | 76.51 mmhg | Standard Deviation 5.19 |
| Group-I | Diastolic Blood Pressure | 3 min after ETT insertion | 76.24 mmhg | Standard Deviation 4.04 |
| Group-I | Diastolic Blood Pressure | Baseline | 79.96 mmhg | Standard Deviation 5.88 |
| Group-I | Diastolic Blood Pressure | 5 min after ETT insertion | 76.03 mmhg | Standard Deviation 4.38 |
| Group-I | Diastolic Blood Pressure | SGA insertion | 75.24 mmhg | Standard Deviation 5.13 |
| Group-I | Diastolic Blood Pressure | 7 min after ETT insertion | 76.1 mmhg | Standard Deviation 4.38 |
| Group-I | Diastolic Blood Pressure | After Dex injection | 71.24 mmhg | Standard Deviation 7.67 |
| Group-I | Diastolic Blood Pressure | 10 min after ETT insertion | 77.37 mmhg | Standard Deviation 3.6 |
| Group-I | Diastolic Blood Pressure | V. Bougie insertion | 77.03 mmhg | Standard Deviation 4.22 |
| Group-I | Diastolic Blood Pressure | 15 min after ETT insertion | 77.1 mmhg | Standard Deviation 4.35 |
| Group-I | Diastolic Blood Pressure | After induction | 70.1 mmhg | Standard Deviation 7.99 |
| Group-C | Diastolic Blood Pressure | 15 min after ETT insertion | 76.79 mmhg | Standard Deviation 5.48 |
| Group-C | Diastolic Blood Pressure | After Dex injection | 73.68 mmhg | Standard Deviation 9.03 |
| Group-C | Diastolic Blood Pressure | Baseline | 81.51 mmhg | Standard Deviation 6.57 |
| Group-C | Diastolic Blood Pressure | After induction | 72.79 mmhg | Standard Deviation 8.64 |
| Group-C | Diastolic Blood Pressure | SGA insertion | 75.17 mmhg | Standard Deviation 8.37 |
| Group-C | Diastolic Blood Pressure | V. Bougie insertion | 76.51 mmhg | Standard Deviation 6.4 |
| Group-C | Diastolic Blood Pressure | 3 min after ETT insertion | 75.34 mmhg | Standard Deviation 5.72 |
| Group-C | Diastolic Blood Pressure | 5 min after ETT insertion | 75.03 mmhg | Standard Deviation 6.57 |
| Group-C | Diastolic Blood Pressure | 7 min after ETT insertion | 75.72 mmhg | Standard Deviation 5.22 |
| Group-C | Diastolic Blood Pressure | 10 min after ETT insertion | 76.79 mmhg | Standard Deviation 6.96 |
| Group-C | Diastolic Blood Pressure | ETT insertion | 75.68 mmhg | Standard Deviation 5.5 |
Heart Rate
Heart rate to observe at the following time intervals. 1. Base line 2. After induction 3. After dexmedetomidine injection 4. Supraglottic airway insertion 5. Ventilating bougie insertion 6. ETT insertion 7. 3minute after ETT insertion 8. 5 minute after ETT insertion 9. 7 minute after ETT insertion 10. 10 minute after ETT insertion 11. 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.
Time frame: 25 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group-I | Heart Rate | ETT insertion | 83.27 beats per minute | Standard Deviation 9.75 |
| Group-I | Heart Rate | 3 min after ETT insertion | 83.75 beats per minute | Standard Deviation 8.78 |
| Group-I | Heart Rate | After Dex injection | 71.24 beats per minute | Standard Deviation 9.98 |
| Group-I | Heart Rate | 5 min after ETT insertion | 81.17 beats per minute | Standard Deviation 6.99 |
| Group-I | Heart Rate | SGA insertion | 75.68 beats per minute | Standard Deviation 9.41 |
| Group-I | Heart Rate | 7 min after ETT insertion | 81.86 beats per minute | Standard Deviation 7.01 |
| Group-I | Heart Rate | Baseline | 91.06 beats per minute | Standard Deviation 11.72 |
| Group-I | Heart Rate | 10 min after ETT insertion | 80.86 beats per minute | Standard Deviation 6.53 |
| Group-I | Heart Rate | V. Bougie insertion | 85.55 beats per minute | Standard Deviation 6.6 |
| Group-I | Heart Rate | 15 min after ETT insertion | 81.13 beats per minute | Standard Deviation 5.87 |
| Group-I | Heart Rate | After induction | 69.87 beats per minute | Standard Deviation 11.81 |
| Group-C | Heart Rate | 15 min after ETT insertion | 78.41 beats per minute | Standard Deviation 8.02 |
| Group-C | Heart Rate | Baseline | 88.89 beats per minute | Standard Deviation 9.76 |
| Group-C | Heart Rate | After Dex injection | 72.75 beats per minute | Standard Deviation 10.76 |
| Group-C | Heart Rate | After induction | 74.1 beats per minute | Standard Deviation 11.17 |
| Group-C | Heart Rate | SGA insertion | 78.79 beats per minute | Standard Deviation 9.73 |
| Group-C | Heart Rate | V. Bougie insertion | 82.41 beats per minute | Standard Deviation 5.78 |
| Group-C | Heart Rate | 3 min after ETT insertion | 82.72 beats per minute | Standard Deviation 7.65 |
| Group-C | Heart Rate | 5 min after ETT insertion | 79 beats per minute | Standard Deviation 8.62 |
| Group-C | Heart Rate | 7 min after ETT insertion | 79.34 beats per minute | Standard Deviation 7.31 |
| Group-C | Heart Rate | 10 min after ETT insertion | 78.79 beats per minute | Standard Deviation 6.39 |
| Group-C | Heart Rate | ETT insertion | 81.65 beats per minute | Standard Deviation 5.94 |
Systolic Blood Pressure
Systolic blood pressure measured at following time intervals. 1. Base line 2. After Dexmedetomidine injection 3. After induction of anaesthesia 4. Supraglottic airway insertion 5. Ventilating bougie insertion 6. ETT insertion 7. 3 minute after ETT insertion 8. 5 minute after ETT insertion 9. 7 minute after ETT insertion 10. 10 minute after ETT insertion 11. 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.
Time frame: 25 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group-I | Systolic Blood Pressure | SGA insertion | 113.93 mmhg | Standard Deviation 6.14 |
| Group-I | Systolic Blood Pressure | 3 min after ETT insertion | 116.03 mmhg | Standard Deviation 4.91 |
| Group-I | Systolic Blood Pressure | Baseline | 122.31 mmhg | Standard Deviation 8.07 |
| Group-I | Systolic Blood Pressure | 5 min after ETT insertion | 118.62 mmhg | Standard Deviation 5.36 |
| Group-I | Systolic Blood Pressure | V. Bougie insertion | 118.65 mmhg | Standard Deviation 5.17 |
| Group-I | Systolic Blood Pressure | 7 min after ETT insertion | 115.13 mmhg | Standard Deviation 5.35 |
| Group-I | Systolic Blood Pressure | After Dex injection | 109.96 mmhg | Standard Deviation 8.15 |
| Group-I | Systolic Blood Pressure | 10 min after ETT insertion | 116.93 mmhg | Standard Deviation 6.55 |
| Group-I | Systolic Blood Pressure | ETT insertion | 117.37 mmhg | Standard Deviation 4.87 |
| Group-I | Systolic Blood Pressure | 15 min after ETT insertion | 116.62 mmhg | Standard Deviation 6.61 |
| Group-I | Systolic Blood Pressure | After induction | 108.03 mmhg | Standard Deviation 8.34 |
| Group-C | Systolic Blood Pressure | 15 min after ETT insertion | 118.1 mmhg | Standard Deviation 9.54 |
| Group-C | Systolic Blood Pressure | Baseline | 125.31 mmhg | Standard Deviation 11.06 |
| Group-C | Systolic Blood Pressure | After Dex injection | 114.34 mmhg | Standard Deviation 12.41 |
| Group-C | Systolic Blood Pressure | After induction | 112.51 mmhg | Standard Deviation 10.53 |
| Group-C | Systolic Blood Pressure | SGA insertion | 114.24 mmhg | Standard Deviation 6.62 |
| Group-C | Systolic Blood Pressure | V. Bougie insertion | 116.10 mmhg | Standard Deviation 4.73 |
| Group-C | Systolic Blood Pressure | ETT insertion | 117.93 mmhg | Standard Deviation 6.7 |
| Group-C | Systolic Blood Pressure | 3 min after ETT insertion | 118.31 mmhg | Standard Deviation 8.1 |
| Group-C | Systolic Blood Pressure | 5 min after ETT insertion | 118.31 mmhg | Standard Deviation 8.1 |
| Group-C | Systolic Blood Pressure | 7 min after ETT insertion | 115.79 mmhg | Standard Deviation 6.95 |
| Group-C | Systolic Blood Pressure | 10 min after ETT insertion | 116.96 mmhg | Standard Deviation 10.95 |