Annals of medicine · 2023
Modified anterior approach versus traditional posterior approach for ultrasound-guided superior laryngeal nerve block in awake endotracheal intubation: a randomized non-inferiority clinical trial.
Equivalence TrialСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Huang Qiyuan, Hua Yusi, Zhou Ruihao, Chen Guo, Zhu Tao
Аннотация
STUDY OBJECTIVE: This study was undertaken to compare the effect of the modified ultrasound-guided anterior superior laryngeal nerve block (SLNB) with the traditional ultrasound-guided posterior SLNB in providing intubation conditions during awake tracheal intubation (ATI) in patients without difficult airway.
DESIGN: Randomized, assessor-blind. Registration number: ChiCTR2200058086.
SETTING: West China Hospital of Sichuan University, Chengdu, China.
PATIENTS: 104 patients aged 18-65 years, of American Society of Anesthesiologists status I-III, posted for elective general surgery with general endotracheal anesthesia.
INTERVENTIONS: The patients were randomized into two groups (modified group, n = 52; traditional group, n = 52). Modified anterior SLNB or traditional posterior SLNB was performed under ultrasound guidance.
MEASUREMENTS: The primary outcome was the proportion of acceptable intubation condition (AIC), which was analyzed in both per-protocol (PP) and intention-to-treat (ITT) populations. The prespecified non-inferiority margin was -4.8%. Secondary outcomes included intubation success rate on the first attempt, hemodynamic parameters during ATI, time taken for airway anesthesia and intubation, recall of intubation, patient perception of comfort, and incidence and severity of postoperative complications.
MAIN RESULTS: In the PP population, the proportion of AIC in the modified group was 49/49 (100%) and that in the traditional group was 49/49 (100%), absolute difference 0, lower limit of 1-sided 95% CI, -0.3%. In the ITT population, the primary outcomes in the modified and traditional group were 52/52 (100%) and 51/52 (98.1%), respectively, with an absolute difference of 1.9% and a lower limit of 1-sided 95% CI of -1.2%. The non-inferiority of modified ultrasound-guided anterior SLNB was confirmed in both populations.
CONCLUSIONS: Among adults without difficult airways during videolaryngoscope-assisted ATI, the modified ultrasound-guided anterior SLNB, compared to the traditional posterior approach, showed a statistically non-inferior effect in terms of providing AIC.
DESIGN: Randomized, assessor-blind. Registration number: ChiCTR2200058086.
SETTING: West China Hospital of Sichuan University, Chengdu, China.
PATIENTS: 104 patients aged 18-65 years, of American Society of Anesthesiologists status I-III, posted for elective general surgery with general endotracheal anesthesia.
INTERVENTIONS: The patients were randomized into two groups (modified group, n = 52; traditional group, n = 52). Modified anterior SLNB or traditional posterior SLNB was performed under ultrasound guidance.
MEASUREMENTS: The primary outcome was the proportion of acceptable intubation condition (AIC), which was analyzed in both per-protocol (PP) and intention-to-treat (ITT) populations. The prespecified non-inferiority margin was -4.8%. Secondary outcomes included intubation success rate on the first attempt, hemodynamic parameters during ATI, time taken for airway anesthesia and intubation, recall of intubation, patient perception of comfort, and incidence and severity of postoperative complications.
MAIN RESULTS: In the PP population, the proportion of AIC in the modified group was 49/49 (100%) and that in the traditional group was 49/49 (100%), absolute difference 0, lower limit of 1-sided 95% CI, -0.3%. In the ITT population, the primary outcomes in the modified and traditional group were 52/52 (100%) and 51/52 (98.1%), respectively, with an absolute difference of 1.9% and a lower limit of 1-sided 95% CI of -1.2%. The non-inferiority of modified ultrasound-guided anterior SLNB was confirmed in both populations.
CONCLUSIONS: Among adults without difficult airways during videolaryngoscope-assisted ATI, the modified ultrasound-guided anterior SLNB, compared to the traditional posterior approach, showed a statistically non-inferior effect in terms of providing AIC.