A novel cricoid pressure sensor device enhances the efficacy of oesophageal occlusion during Sellick's manoeuvre: A randomised controlled trial.

Background: The inability to measure the force applied during cricoid pressure is an important limitation in clinical practice. We developed a novel device to measure this force and provide real-time feedback to the operator.

Objectives: To test the hypothesis of superior oesophageal occlusion during cricoid pressure when guided by the novel device as compared with conventional practice.

Design: A prospective randomised controlled trial.

Setting: Tertiary University Hospital, May to December 2021.

Patients: Sixty-five ASA I/II adult patients of either sex scheduled for elective surgery under general anaesthesia requiring tracheal intubation. Patients with comorbidities involving the neck, those at risk of pulmonary aspiration, anticipated difficult airway and BMI at least 35 kg  m -2 were excluded.

Intervention: Operators applied cricoid pressure with their fingers in both groups. Participants were randomised into 'feedback group' where the operator adjusted this force based on the force measured by the novel device, and 'control group' where the force measured by the device was shielded from the operator.

Main outcome measures: The primary outcome was the rate of occlusion of oesophageal opening assessed by whether a 12 CH orogastric tube could be inserted into the oesophageal entrance during videolaryngoscopy. Secondary outcomes included the magnitudes of force measured during cricoid pressure, oesophageal diameter measured ultrasonographically during cricoid pressure and intubation parameters.

Results: Sixty-four patients completed the study. The oesophageal opening was occluded in significantly more patients in the feedback group compared with the control group (94 vs. 6%; P  = 0.001). The mean ± SD force (N) applied was significantly better and consistent at all time points in the feedback group compared to the control group (22.65 ± 7.81 vs. 14.57 ± 11.13, P  < 0.001). The median [IQR] anteroposterior diameter of the oesophagus during cricoid pressure was less in the feedback group compared to the control group (0.49 [0.36 to 0.56] vs. 0.57 [0.48 to 0.65], P  = 0.006).

Conclusions: The use of the novel sensor device achieved a significantly high rate of oesophageal occlusion during application of cricoid pressure.

Trial registration: Clinical Trial Registry of India (CTRI/2021/05/033484).