N/A
Completed N=58
I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie
Intubation; Difficult
Source: ClinicalTrials.gov NCT02566135 ↗
Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Attempts for I-gel or Classic-LMA Insertions — 25; 22; 2; 5 attempt — p=0.5033
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Attempts for I-gel or Classic-LMA Insertions |
25; 22; 2; 5; 2; 2 | 0.5033 |
| PRIMARY Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA |
23; 24; 6; 4; 0; 1 | >0.05 |
| PRIMARY Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie |
29; 28; 0; 1; 0; 0 | >0.05 |
| PRIMARY Time of Insertion |
26.17; 44.65; 31.51; 26.31; 25.58; 28.13 | <0.0001 sig |
| PRIMARY Total Intubation Time |
93.27; 108.96 | <0.0001 sig |
| SECONDARY Heart Rate |
91.06; 88.89; 71.24; 72.75; 69.87; 74.1 | 0.44 |
| SECONDARY Systolic Blood Pressure |
122.31; 125.31; 109.96; 114.34; 108.03; 112.51 | 0.24 |
| SECONDARY Diastolic Blood Pressure |
79.96; 81.51; 71.24; 73.68; 70.1; 72.79 | 0.34 |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02566135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.