Comparing the placement of a left-sided double-lumen tube via fiberoptic bronchoscopy guidance versus conventional intubation using a Macintosh laryngoscope, to reduce the incidence of malpositioning: study protocol for a randomized controlled pilot trial.
BACKGROUND : A fiberoptic bronchoscope (FOB) is commonly used to identify the proper placement of a double-lumen endotracheal tube (DLT) for good lung isolation during thoracic surgery. We hypothesized that the FOB-guided method for DLT placement composed of tracheal intubation under initial guidance by a FOB via the bronchial lumen and subsequent selective left-bronchial intubation could be used to reduce the incidence of DLT malposition and reduce the time required for completion of DLT placement and confirmation of proper DLT position during intubation using a left-sided DLT, in comparison to the conventional method under direct laryngoscopy using a Macintosh laryngoscope. METHODS : In this randomized controlled pilot trial, 50 patients, aged 18-70 years, scheduled for elective thoracic surgery will be recruited and randomly assigned to two groups according to the method of DLT placement: a FOB-guided method (F) group and a conventional method (C) group. Regardless of the group, the DLT placement processes will be followed by subsequent confirmation processes, using a FOB. If the DLT is misplaced, the position would be corrected. The primary outcome is the incidence of DLT malpositioning observed via a FOB during confirmation after DLT placement. The secondary outcomes consist of the time required to achieve the entire DLT intubation process, which is the sum of the duration of DLT placement and the duration of confirmation of the proper position, the incidence of failed tracheal intubation on the first and second attempt, and complications associated with the intubation process. CONCLUSIONS : This pilot study was designed as the first randomized controlled trial to confirm our hypothesis. This should provide information for a further full-scale trial, and the outcomes of the study should provide clinical evidence on the usefulness of the FOB-guided method for DLT placement, in comparison to the conventional method. BACKGROUND : Clinical Research Information Service; CRIS, ID: KCT0002663 . Retrospectively registered on 24 January 2018.