UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010184
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

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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 or person

Institute

Dokkyo Medical University, Koshigaya Hospital

Institute

Department

Personal name



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

Value
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
Registered date File name

Research case data
Registered date File name