N/A
N=66
AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA
Supraglottic Airway
Bottom Line
View on ClinicalTrials.gov: NCT01656967 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Total Intubation Time — 89.6; 52.1 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AMBU Aura-I/aScope 2 (Device); LMA Fastrach Single Use (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Intubation Time |
89.6; 52.1 | — |
| SECONDARY Time for Supraglottic Airway (SGA) Insertion |
28.6; 30.3 | — |
| SECONDARY Time for Endotracheal Tube (ETT) Insertion |
60.9; 23.1 | — |
| SECONDARY Number of Participants in Whom SGA Insertion Was Successful on the First Attempt |
30; 30 | — |
| SECONDARY Number of Participants in Whom ETT Insertion Was Successful on the First Attempt |
26; 27 | — |
| SECONDARY Number of Participants With Overall Success for SGA Placement |
30; 30 | — |
| SECONDARY Number of Participant With Overall Intubation Success |
29; 31 | — |
| SECONDARY Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU) |
29; 30 | — |
| SECONDARY Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU) |
29; 30 | — |
Summary
The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in patients undergoing general anesthesia for elective surgery.
Eligibility Criteria
Inclusion Criteria
- Adult surgical Candidates Aged 18-80 years
- ASA I-III
- Mallampati Score of I or II
- BMI ≤ 35 kg/m2
- Presenting for elective surgery
- Require General Endotracheal Anesthesia.
Exclusion Criteria
- Previously known difficult airway,
- Emergency status
- Require prone positioning
- Interincisor distance < 2.5cm
- Thyromental distance < 5cm
- Clinically suspected difficult airway
- Contraindications to LMA Insertion, such as Reflux disease
- Patients who do not require endotracheal intubation
- Indications for Rapid Sequence Induction (RSI)
Data sourced from ClinicalTrials.gov (NCT01656967). 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.