Michael J Malcharek1, Manuel Bartz, Birgit Rogos, Lutz Günther, Armin Sablotzki, Jochen Gille, Gerhard Schneider. 1. From the Department of Anaesthesiology, Intensive Care and Pain Therapy, Klinikum St. Georg gGmbH, Leipzig (MJM, BR, AS, JG), Department of Anaesthesiology and Intensive Care, Kliniken des Landkreises Neumarkt in der Oberpfalz, Neumarkt i. d. Opf., Bavaria (MB), Department of Neurosurgery, Klinikum St. Georg gGmbH, Leipzig (LG), Department of Anaesthesiology, Witten/Herdecke University, Helios Clinic Wuppertal, Nordrhein-Westfalen, Germany (GH) *Michael J. Malcharek and Manuel Bartz contributed equally as first authors of this work and in preparing the original manuscript.
Abstract
BACKGROUND: Two methods of topical anaesthesia for awake fibreoptic intubation (FOI) in patients at risk of secondary cervical injury were compared: the translaryngeal injection (TLI) technique and the Enk Fibreoptic Atomizer. OBJECTIVE: The objective of this study was to determine which system of topical anaesthesia provides the fastest and most comfortable awake FOI, using the oral approach. DESIGN: A randomised controlled study. SETTING: A single centre trial between 2009 and 2011. PATIENTS: One hundred and twenty patients (63 women, 57 men) who underwent neurosurgery of the spine atKlinikum St. Georg Leipzig were randomly allocated into two groups (group TLI, 61 patients; group ENK-ATOMIZER, 59 patients). Inclusion criteria were an American Society of Anesthesiology (ASA) physical status of 1 to 3, age 18 to 80 years, and those who met any one of three indications for FOI - cervical instability, predicted difficult airway, a BMI greater than 40 kg m(-2), and who gave written informed consent.Exclusion criteria were emergency awake FOI, mental disability/delirium, polytrauma and contraindication to TLI. INTERVENTIONS: Two anaesthesiologists experienced in both techniques performed all anaesthesia procedures within the study. MAIN OUTCOME MEASURES: The primary outcome was the timing sequence of awake FOI. The incidence of coughing/gagging, ease of tracheal tube placement, mucosal bleeding, cardiopulmonary stability and postoperative outcomes were also investigated. RESULTS:Awake FOI was significantly faster using the TLI technique (mean, 191 s; range, 123 to 447 s; SD, 83.5) than the Enk Fibreoptic Atomizer [mean, 430 s; range, 275 to 773 s; SD, 124.9; (P = 0.0001)]. Patients in group TLI exhibited significantly less gagging (P = 0.047) but more mucosal bleeding (P < .001). CONCLUSION:Awake FOI using the TLI technique was faster and provided better topical anaesthesia with less gagging during endoscopic intubation. However, the TLI technique was also more invasive. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00948350.
RCT Entities:
BACKGROUND: Two methods of topical anaesthesia for awake fibreoptic intubation (FOI) in patients at risk of secondary cervical injury were compared: the translaryngeal injection (TLI) technique and the Enk Fibreoptic Atomizer. OBJECTIVE: The objective of this study was to determine which system of topical anaesthesia provides the fastest and most comfortable awake FOI, using the oral approach. DESIGN: A randomised controlled study. SETTING: A single centre trial between 2009 and 2011. PATIENTS: One hundred and twenty patients (63 women, 57 men) who underwent neurosurgery of the spine at Klinikum St. Georg Leipzig were randomly allocated into two groups (group TLI, 61 patients; group ENK-ATOMIZER, 59 patients). Inclusion criteria were an American Society of Anesthesiology (ASA) physical status of 1 to 3, age 18 to 80 years, and those who met any one of three indications for FOI - cervical instability, predicted difficult airway, a BMI greater than 40 kg m(-2), and who gave written informed consent.Exclusion criteria were emergency awake FOI, mental disability/delirium, polytrauma and contraindication to TLI. INTERVENTIONS: Two anaesthesiologists experienced in both techniques performed all anaesthesia procedures within the study. MAIN OUTCOME MEASURES: The primary outcome was the timing sequence of awake FOI. The incidence of coughing/gagging, ease of tracheal tube placement, mucosal bleeding, cardiopulmonary stability and postoperative outcomes were also investigated. RESULTS: Awake FOI was significantly faster using the TLI technique (mean, 191 s; range, 123 to 447 s; SD, 83.5) than the Enk Fibreoptic Atomizer [mean, 430 s; range, 275 to 773 s; SD, 124.9; (P = 0.0001)]. Patients in group TLI exhibited significantly less gagging (P = 0.047) but more mucosal bleeding (P < .001). CONCLUSION: Awake FOI using the TLI technique was faster and provided better topical anaesthesia with less gagging during endoscopic intubation. However, the TLI technique was also more invasive. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00948350.