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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010184
Receipt No. 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

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Basic information
Public title Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Acronym Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Scientific Title Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Scientific Title:Acronym Effect of cricoid pressure on placement of the I-gelTM : a randomized study
Region
Japan

Condition
Condition We study 40 patients who have elective surgery in general anesthesia.
They are all over 20 years old men, and women, of ASA1-2.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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,
Key secondary outcomes We insert fiberscope into the i-gel.
We evaluate a glottis view through fiberscope.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 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.
Interventions/Control_2 Intervention group 2 is insertion of the i-gel without cricoid pressure.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We study 40 patients who have elective surgery in general anesthesia.
They are all over 20 years old men, and women, of ASA1-2.
Key exclusion 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhisa Okuda
Organization Dokkyo Medical University, Koshigaya Hospital
Division name Department of Anesthesiology
Zip code
Address Minami-koshigaya, 2-1-50 Koshigaya, Saitama, Japan
TEL 048-969-4948
Email yuichi.d-k.aneth@ktf.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hashimoto Yuichi
Organization Dokkyo Medical University, Koshigaya Hospital
Division name Department of Anesthesiology
Zip code
Address Minami-koshigaya, 2-1-50 Koshigaya, Saitama, Japan
TEL 048-969-4948
Homepage URL
Email yuichi.d-k.aneth@ktf.biglobe.ne.jp

Sponsor
Institute Dokkyo Medical University, Koshigaya Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 獨協医科大学越谷病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 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.

Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 02 Month 01 Day
Date of closure to data entry
2014 Year 02 Month 01 Day
Date trial data considered complete
2014 Year 02 Month 01 Day
Date analysis concluded
2014 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 06 Day
Last modified on
2016 Year 01 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011777

Research Plan
Registered date File name

Research case data specifications
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Research case data
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