Unique ID issued by UMIN | UMIN000010184 |
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Receipt number | R000011777 |
Scientific Title | Effect of cricoid pressure on placement of the I-gelTM : a randomized study |
Date of disclosure of the study information | 2013/04/01 |
Last modified on | 2016/01/02 19:26:28 |
Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Japan |
We study 40 patients who have elective surgery in general anesthesia.
They are all over 20 years old men, and women, of ASA1-2.
Anesthesiology |
Others
NO
The laryngeal mask airway has successfully been used to permit ventilation of the lungs in patients in whom manual ventilation via a facemask or tracheal intubation had failed (cannot intubate, cannot ventilate scenario). In the patient at an increased risk of pulmonary aspiration, it is necessary to apply cricoid pressure, because the laryngeal mask cannot prevent regurgitation of gastric contents. Nevertheless, Cricoid pressure may frequently hamper placement of the laryngeal mask. The theoretical reason for this difficulty is that, because the shape of the laryngeal mask is designed based on the shape of the hypopharynx, cricoid pressure, which compresses the hypopharynx, should prevent the distal part of the laryngeal mask from occupying the hypopharynx.
The I-gelTM airway (Intersurgical Ltd, Wokingham, Berkshire, UK) is a relatively new single-use supraglottic airway device made up of a thermoplastic elastomer (SEBS, styrene ethylene butadiene styrene) with a soft and gel-like feel. The device holds a drainage tube and bite-block mechanism. The i-gel can be placed easily and rapidly, providing a clear airway in over 90% of cases. It has also been used successfully as an airway rescue in cannot intubate, cannot ventilate scenario. The most characteristic feature of the i-gel is that the mask part is designed to mirror perilaryngeal structures and fit these structures, without the use of an inflatable cuff. Because the i-gel is designed based on the larynx, and not on the hypopharynx, we hypothesized that placement of the i-gel would be easy even under cricoid pressure. We studied about this hypothesis, by assessing the success rate of adequate ventilation through the i-gel.
Efficacy
Confirmatory
Pragmatic
Not applicable
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,
We insert fiberscope into the i-gel.
We evaluate a glottis view through fiberscope.
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
2
Treatment
Device,equipment | Maneuver |
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.
18 | years-old | <= |
Not applicable |
Male and Female
We study 40 patients who have elective surgery in general anesthesia.
They are all over 20 years old men, and women, of ASA1-2.
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.
40
1st name | |
Middle name | |
Last name | Yasuhisa Okuda |
Dokkyo Medical University, Koshigaya Hospital
Department of Anesthesiology
Minami-koshigaya, 2-1-50 Koshigaya, Saitama, Japan
048-969-4948
yuichi.d-k.aneth@ktf.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Hashimoto Yuichi |
Dokkyo Medical University, Koshigaya Hospital
Department of Anesthesiology
Minami-koshigaya, 2-1-50 Koshigaya, Saitama, Japan
048-969-4948
yuichi.d-k.aneth@ktf.biglobe.ne.jp
Dokkyo Medical University, Koshigaya Hospital
none
Self funding
NO
獨協医科大学越谷病院(埼玉県)
2013 | Year | 04 | Month | 01 | Day |
Published
We approached 43 patients, and studied 40 patients whose parents gave informed consent. The lungs could be ventilated through the facemask in all patients before and after application of cricoid or sham pressure. There were no patients who had arterial haemoglobin oxygen saturation (SpO2) decreased to less than 95% and withdrawn from the study.
Under sham pressure, the i-gel was placed and adequate ventilation was obtained in all patients. In contrast, under cricoid pressure, adequate ventilation could be obtained in 34 of 40 patients (85%). There was a significant difference (P < 0.05) in the success rate between cricoid pressure and sham pressure (15% difference; 95%CI for difference: 4 - 26%McNemar test). The time to achieve adequate ventilation was significantly longer (P < 0.05) with cricoid pressure than without (median difference: 8 s; 95%CI for median difference: 3 - 12 s Wilcoxon test).
Fibrescopy indicated that the i-gel was in the optimal position in 39 of 40 patients with sham pressure, and in 17 patients with cricoid pressure. Cricoid pressure significantly decreased (P < 0.001) the proportion of the optimal position, and significantly increased the incidence of malposition (P < 0.001 McNemar test).
After anaesthesia, one patient had sore throat, without sequelae.
Completed
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2013 | Year | 03 | Month | 06 | Day |
2016 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011777
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