General Anesthesia Clinical Trial
Official title:
Impact of Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure
This study is aimed to provide the evidence that ultrasound-guided identification of the cricoid cartilage can improve effectiveness of cricoid pressure. Ultrasound (US) is well recognized as a technique for identifying the neck landmarks including the cricoid cartilage. Based on the potential results that may show that US could be a tool for improve the effectiveness of cricoid pressure, the investigators expect to disseminate this knowledge to be transformed in the standard technique for helping anesthesiologists and nurses to do pressure in the correct location. It is expected that the greatest impact of this study will lead to improved patient outcomes and safety, particularly in the ones with high-risk for aspiration.
This is a prospective two-arm randomized controlled single blinded study to be conducted at
Mount Sinai Hospital, University of Toronto. The study will be conducted in the operating
rooms (OR) with patients as subjects, and OR nurses and scheduled anesthesiologists as
participants.Following signed informed consent, patients will be randomized into two
groups:(i) Control group (CPG, n=65): cricoid pressure applied by the OR nurse on the cricoid
cartilage using finger palpation without ultrasonography and (ii) Ultrasound group (USG,
n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage after localization
with US. The oesophagus of the patient participants in both groups will also be identified by
US. A portable US machine will be present in the operating room for all patients in both
groups.
The anesthesiologist scheduled for the surgery is blinded to group allocation and will induce
the patient with general anesthesia. The anesthesiologist will provide adequate oxygenation
with 100% oxygen to reach an end-tidal oxygen ≥ 90% using mask ventilation. Thereafter, the
scheduled anesthesiologist will step out of the operating room. Apneic oxygenation will be
maintained using a nasal cannula with 100% oxygen at 5 litres/min. During apneic oxygenation,
one of the research anesthesiologists will localize the cricoid cartilage using US (for
patients in USG group). Prior to applying cricoid pressure, the nurse will be instructed to
use an estimated pressure (of 30 Newtons) that causes discomfort when applied to his/her
nasal bridge. The nurse will then apply an estimated 30 Newtons pressure on the cricoid
cartilage localized by US for patients in the USG group or blindly without US for patients in
CPG group.
The anesthesiologist will then return to the operating room and perform a videolaryngoscopy
to directly visualize up to three attempts to pass a lubricated 20F gastric tube at the upper
outlet of the esophagus with (i) pressure directly on the cricoid cartilage and (ii) with
pressure on the cricoid cartilage shifted to the left and right of the midline. Following
removal of the gastric tube and videolaryngoscope, the trachea will be intubated using direct
laryngoscopy with a McIntosh blade. Cricoid pressure will be released after the cuff of the
endotracheal tube is inflated. Thereafter, the location of the CC (blindly without US) for
patients in CPG group will be marked and compared to the location that will be identified
with US.
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