Trial Outcomes & Findings for I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie (NCT NCT02566135)
NCT ID: NCT02566135
Last Updated: 2018-07-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
60 seconds
Results posted on
2018-07-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie
Baseline characteristics by cohort
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.03 Years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
36.13 Years
STANDARD_DEVIATION 11.24 • n=7 Participants
|
35.58 Years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
ASAPS ( American society of Anaesthesiologist's physical ststus
ASAPS I
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
ASAPS ( American society of Anaesthesiologist's physical ststus
ASAPS II
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
BMI (body mass index)
|
21.30 Kg/m2
STANDARD_DEVIATION 2.96 • n=5 Participants
|
21.43 Kg/m2
STANDARD_DEVIATION 2.19 • n=7 Participants
|
21.36 Kg/m2
STANDARD_DEVIATION 2.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: 60 secondsOutcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Number of Attempts for I-gel or Classic-LMA Insertions
1st attempt
|
25 attempt
|
22 attempt
|
|
Number of Attempts for I-gel or Classic-LMA Insertions
2nd attempt
|
2 attempt
|
5 attempt
|
|
Number of Attempts for I-gel or Classic-LMA Insertions
3rd attempt
|
2 attempt
|
2 attempt
|
PRIMARY outcome
Timeframe: 45 secondsOutcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
1st attempt
|
23 attempt
|
24 attempt
|
|
Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
2nd attempt
|
6 attempt
|
4 attempt
|
|
Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
3rd attempt
|
0 attempt
|
1 attempt
|
PRIMARY outcome
Timeframe: 30 secondsOutcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
1st attempt
|
29 attempt
|
28 attempt
|
|
Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
2nd attempt
|
0 attempt
|
1 attempt
|
|
Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
3rd attempt
|
0 attempt
|
0 attempt
|
PRIMARY outcome
Timeframe: 5 minutesOutcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Time of Insertion
Supraglottic airway
|
26.17 Seconds
Standard Deviation 2.25
|
44.65 Seconds
Standard Deviation 9.14
|
|
Time of Insertion
Ventilating bougie
|
31.51 Seconds
Standard Deviation 8.87
|
26.31 Seconds
Standard Deviation 9.25
|
|
Time of Insertion
ETT
|
25.58 Seconds
Standard Deviation 4.01
|
28.13 Seconds
Standard Deviation 8.31
|
PRIMARY outcome
Timeframe: 5 minutesOutcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Total Intubation Time
|
93.27 Second
Standard Deviation 9.03
|
108.96 Second
Standard Deviation 16.50
|
SECONDARY outcome
Timeframe: 25 minutesHeart 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.
Outcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Heart Rate
Baseline
|
91.06 beats per minute
Standard Deviation 11.72
|
88.89 beats per minute
Standard Deviation 9.76
|
|
Heart Rate
After Dex injection
|
71.24 beats per minute
Standard Deviation 9.98
|
72.75 beats per minute
Standard Deviation 10.76
|
|
Heart Rate
After induction
|
69.87 beats per minute
Standard Deviation 11.81
|
74.1 beats per minute
Standard Deviation 11.17
|
|
Heart Rate
SGA insertion
|
75.68 beats per minute
Standard Deviation 9.41
|
78.79 beats per minute
Standard Deviation 9.73
|
|
Heart Rate
V. Bougie insertion
|
85.55 beats per minute
Standard Deviation 6.60
|
82.41 beats per minute
Standard Deviation 5.78
|
|
Heart Rate
ETT insertion
|
83.27 beats per minute
Standard Deviation 9.75
|
81.65 beats per minute
Standard Deviation 5.94
|
|
Heart Rate
3 min after ETT insertion
|
83.75 beats per minute
Standard Deviation 8.78
|
82.72 beats per minute
Standard Deviation 7.65
|
|
Heart Rate
5 min after ETT insertion
|
81.17 beats per minute
Standard Deviation 6.99
|
79 beats per minute
Standard Deviation 8.62
|
|
Heart Rate
7 min after ETT insertion
|
81.86 beats per minute
Standard Deviation 7.01
|
79.34 beats per minute
Standard Deviation 7.31
|
|
Heart Rate
10 min after ETT insertion
|
80.86 beats per minute
Standard Deviation 6.53
|
78.79 beats per minute
Standard Deviation 6.39
|
|
Heart Rate
15 min after ETT insertion
|
81.13 beats per minute
Standard Deviation 5.87
|
78.41 beats per minute
Standard Deviation 8.02
|
SECONDARY outcome
Timeframe: 25 minutesSystolic 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.
Outcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Systolic Blood Pressure
After induction
|
108.03 mmhg
Standard Deviation 8.34
|
112.51 mmhg
Standard Deviation 10.53
|
|
Systolic Blood Pressure
Baseline
|
122.31 mmhg
Standard Deviation 8.07
|
125.31 mmhg
Standard Deviation 11.06
|
|
Systolic Blood Pressure
After Dex injection
|
109.96 mmhg
Standard Deviation 8.15
|
114.34 mmhg
Standard Deviation 12.41
|
|
Systolic Blood Pressure
SGA insertion
|
113.93 mmhg
Standard Deviation 6.14
|
114.24 mmhg
Standard Deviation 6.62
|
|
Systolic Blood Pressure
V. Bougie insertion
|
118.65 mmhg
Standard Deviation 5.17
|
116.10 mmhg
Standard Deviation 4.73
|
|
Systolic Blood Pressure
ETT insertion
|
117.37 mmhg
Standard Deviation 4.87
|
117.93 mmhg
Standard Deviation 6.70
|
|
Systolic Blood Pressure
3 min after ETT insertion
|
116.03 mmhg
Standard Deviation 4.91
|
118.31 mmhg
Standard Deviation 8.1
|
|
Systolic Blood Pressure
5 min after ETT insertion
|
118.62 mmhg
Standard Deviation 5.36
|
118.31 mmhg
Standard Deviation 8.1
|
|
Systolic Blood Pressure
7 min after ETT insertion
|
115.13 mmhg
Standard Deviation 5.35
|
115.79 mmhg
Standard Deviation 6.95
|
|
Systolic Blood Pressure
10 min after ETT insertion
|
116.93 mmhg
Standard Deviation 6.55
|
116.96 mmhg
Standard Deviation 10.95
|
|
Systolic Blood Pressure
15 min after ETT insertion
|
116.62 mmhg
Standard Deviation 6.61
|
118.1 mmhg
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: 25 minutesDiastolic 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.
Outcome measures
| Measure |
Group-I
n=29 Participants
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.
|
Group-C
n=29 Participants
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.
|
|---|---|---|
|
Diastolic Blood Pressure
Baseline
|
79.96 mmhg
Standard Deviation 5.88
|
81.51 mmhg
Standard Deviation 6.57
|
|
Diastolic Blood Pressure
After Dex injection
|
71.24 mmhg
Standard Deviation 7.67
|
73.68 mmhg
Standard Deviation 9.03
|
|
Diastolic Blood Pressure
After induction
|
70.1 mmhg
Standard Deviation 7.99
|
72.79 mmhg
Standard Deviation 8.64
|
|
Diastolic Blood Pressure
SGA insertion
|
75.24 mmhg
Standard Deviation 5.13
|
75.17 mmhg
Standard Deviation 8.37
|
|
Diastolic Blood Pressure
V. Bougie insertion
|
77.03 mmhg
Standard Deviation 4.22
|
76.51 mmhg
Standard Deviation 6.40
|
|
Diastolic Blood Pressure
ETT insertion
|
76.51 mmhg
Standard Deviation 5.19
|
75.68 mmhg
Standard Deviation 5.50
|
|
Diastolic Blood Pressure
3 min after ETT insertion
|
76.24 mmhg
Standard Deviation 4.04
|
75.34 mmhg
Standard Deviation 5.72
|
|
Diastolic Blood Pressure
5 min after ETT insertion
|
76.03 mmhg
Standard Deviation 4.38
|
75.03 mmhg
Standard Deviation 6.57
|
|
Diastolic Blood Pressure
7 min after ETT insertion
|
76.1 mmhg
Standard Deviation 4.38
|
75.72 mmhg
Standard Deviation 5.22
|
|
Diastolic Blood Pressure
10 min after ETT insertion
|
77.37 mmhg
Standard Deviation 3.60
|
76.79 mmhg
Standard Deviation 6.96
|
|
Diastolic Blood Pressure
15 min after ETT insertion
|
77.1 mmhg
Standard Deviation 4.35
|
76.79 mmhg
Standard Deviation 5.48
|
Adverse Events
Group-I
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group-C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group-I
n=29 participants at risk
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.
|
Group-C
n=29 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Airway trauma
|
6.9%
2/29 • Number of events 2 • 24 hours
|
10.3%
3/29 • Number of events 3 • 24 hours
|
|
Surgical and medical procedures
Tube impingement
|
0.00%
0/29 • 24 hours
|
3.4%
1/29 • Number of events 1 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place