Effect of cricoid pressure on placement of the I-gelTM : a randomized study

UMIN ID: UMIN000010184

Registered date:01/04/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: We study 40 patients who have elective surgery in general anesthesia. They are all over 20 years old men, and women, of ASA1-2.
• Date of first enrollment: 2013/04/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

We studied 40 adult patients to see if cricoid pressure affected placement of the i-gel. In a randomized crossover design, the i-gel was placed with and without cricoid pressure, and compared the success rate of adequate ventilation through the i-gel, time to placement, and the rate of optimal position of the device between two circumstances.The i-gel was placed while cricoid pressure was applied on one occasion and with no pressure (sham pressure) on the other occasion. The order was randomized by using a sealed envelop which contained the sequence produced by computer random allocation. Cricoid pressure was applied with a standardized force of 30N.Anaesthetic assistants had been trained to apply the correct force, by practicing on a weighing scale with a top board. Sham pressure was applied by placing fingers on the cricoid cartilage without force. During applying cricoid or sham pressure, the assistant supported the patients neck by placing the other hand under the neck to prevent flexion of the head ,bimanual method. To blind the investigator, the patients neck and the assistants hands were covered by a non-transparent drape. If ventilation through a facemask was difficult, the patient was withdrawn from the study.In patients in whom ventilation through a facemask had been adequate, the investigator attempt to place the i-gel by using the method described in the manufacturers instruction manual.Only one attempt at placement of the i-gel was allowed for each occasion. The i-gel was then connected to the breathing system and adequacy of ventilation was assessed. The second assistant measured the time to placement, from holding the i-gel to the first adequate ventilation after its placement. If it was not possible to ventilate adequately, adjustments of the position of the i-gel were allowed up to 1 min. If it was not possible to place the i-gel within 1 min, placement was judged as failure.
Intervention group 2 is insertion of the i-gel without cricoid pressure.

Outcome(s)

• Primary Outcome: We studied 40 adult patients to see if cricoid pressure affected placement of the i-gel. In a randomized crossover design, the i-gel was placed with and without cricoid pressure, and compared the success rate of adequate ventilation through the i-gel, time to placement,
• Secondary Outcome: We insert fiberscope into the i-gel. We evaluate a glottis view through fiberscope.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: We exclude a patient who has cervical or upper airway disease. We exclude a patient who has a risk of aspiration. Before the surgery, we exclude a patient who expected to have a risk of cannot intubate/cannot ventilate of facemask scenario.(CICV) We exclude a case of decreasing SPO2 under 95%, during this study. We exclude a case of cannot ventilate by facemask, after induction of general anesthesia. We exclude a patient who dose not accept this study.

Related Information

• Primary Sponsor: Dokkyo Medical University, Koshigaya Hospital
• Source(s) of Monetary Support: none