N/A N=58 Randomized Treatment

I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie

Intubation; Difficult

Bottom Line

View on ClinicalTrials.gov: NCT02566135 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Number of Attempts for I-gel or Classic-LMA Insertions — 25; 22; 2; 5 attempt — p=0.5033

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tracheal Intubation using I-gel and ventilating bougie (Device); Tracheal Intubation using C-LMA and ventilating bougie (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Medical College Baroda
Primary completion: Jan 2015

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

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.

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.

View full record on ClinicalTrials.gov →

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.