Usefulness of Airway Scope for intubation of infants with cleft lip and palate–comparison with Macintosh laryngoscope: a randomized controlled trial

BACKGROUND: Airway Scope (AWS) with its plastic blade does not require a head-tilt or separate laryngoscopy to guide intubations. Therefore, we hypothesized that its use would reduce the intubation time (IT) and the frequency of airway complication events when compared with the use of Macintosh Laryngoscope (ML) for infants with cleft lip and palate (CLP). METHODS: The parents of all patients provided written consents; we enrolled 40 infants with CLP (ASA-PS 1). After inducing general anesthesia using sevoflurane and rocuronium, we performed orotracheal intubations using either AWS (n = 20) or ML (n = 20), randomly. We define the duration between manual manipulation using cross finger for maximum mouth opening and the first raising motion of the chest following intubation by artificial ventilation as “IT;” further, the measured IT as primary outcomes. Airway complications were considered secondary outcomes. Moreover, we looked for associations between IT and the patient’s characteristics: extensive clefts, age, height, and weight. We used the Mann–Whitney test and Fisher’s exact probability test for statistical analysis; p < 0.05 was considered as statistically significant. RESULTS: The mean IT was 31.5 ± 8.3 s in AWS group and 26.4 ± 8.9 s in ML group. Statistical significant difference was not found in IT between the two groups. The IT of AWS group was statistically related to extensive clefts. Airway complications were detected in ML group. CONCLUSION: AWS could be useful for intubation of infants with CLP; it required IT similar to that required using ML, with a lower rate of airway complications. TRIAL REGISTRATION: UMIN-CTR Registration number UMIN000024763. Registered 8 November 2016.