Condition category
Surgery
Date applied
26/11/2019
Date assigned
16/12/2019
Last edited
16/12/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The aim of this study is to evaluate a new modification of the device used for maintaining a patent airway during procedures under general anaesthesia. This device is the i-gel Plus and it belongs among the supraglottic airway devices. The i-gel Plus device is used for elective procedures and for patients at low risk of gastric content aspiration. The aim is to evaluate the efficacy, insertion characteristics and perioperative/postoperative complications associated with the use of this device.

Who can participate?
Patients indicated for any procedure under general anaesthesia, both genders, aged 18-89, without a significant medical condition.

What does the study involve?
All participants receive identical treatment - intravenous induction to general anaesthesia using routinely used medication and insertion of the i-gel Plus device to the mouth to maintain patent airway during the procedure. At the end of surgery, the i-gel Plus is removed, any blood or gastric fluid on the device is noted and recorded. Postoperative complications are recorded after 1 hour and 24 hours.

What are the possible benefits and risks of participating?
The new device is expected to have a high success rate and a low incidence of adverse effects. Risks are similar to other devices used for maintaining patent airway: sore throat, pain on swallowing after the operation.

Where is the study run from?
This study will be performed in six centres across Europe - two in the Czech Republic (Prague, Olomouc), one in Poland (Lodz), one in Switzerland (Bern), two in the United Kingdom (Antrim, Craigavon). The lead centre is General University Hospital in Prague, Czech Republic.

When is the study starting and how long is it expected to run for?
September 2019 to March 2021

Who is funding the study?
The study is partially funded by the Czech Ministry of Health through the Institutional Support Grant. Other funding comes from the centers/departments involved in the study.

Who is the main contact?
Prof. Pavel Michalek
pavel.michalek@vfn.cz

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pavel Michalek

ORCID ID

http://orcid.org/0000-0001-8119-5927

Contact details

Department of Anaesthesia and Intensive Medicine
General University Hospital in Prague
Prague
12028
Czech Republic
+420 (0)224962666
pavel.michalek@vfn.cz

Type

Public

Additional contact

Dr Jakub Werner

ORCID ID

Contact details

Department of Anaesthesia and Intensive Medicine
General University Hospital in Prague
Prague
12028
Czech Republic
+420 (0)224962243
jakub.werner@vfn.cz

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

U1111-1244-3085

Study information

Scientific title

A prospective evaluation of the i-gel Plus supraglottic airway device in elective procedures

Acronym

i-gel Plus

Study hypothesis

Hypothesis: Total success rate of device insertion will be at least 96%.
Evaluation of total success rate, insertion parameters, perioperative and postoperative complications associated with the insertion of a novel supraglottic airway device i-gel Plus.

Ethics approval

Approved 14/11/2019, Eticka komise Vseobecne fakultni nemocnice v Praze (Ethics Committee of the General University Hospital in Prague) (Na Bojišti 1, 12808 Praha 2, Czech Republic; Tel: +420 (0)224964131; Email: eticka.komise@vfn.cz), ref: 1952/19 S-IV

Study design

Multicentre interventional prospective cohort study. No control

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Airway management in patients under general anaesthesia

Intervention

Intravenous induction with propofol, opioid (fentanyl, sufentanil). Muscle relaxant is not a part of the protocol. If given, for any reason, this must be reported to the CRF. Maintenance – air, oxygen, sevoflurane, boluses of opioid, non-opioid analgesics, controlled ventilation.
Monitoring – routine – ECG, NIBP, pulse oximetry, capnography, invasive monitoring as per the case. Respiratory – peak pressures, plateau pressures, compliance.
At the end of surgery, the i-gel Plus will be removed, any blood or gastric fluid on the device noted and recorded. Postoperative complications will be followed at 1 hour and 24 hours.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Success rate of device insertion (%), defined as the device providing effective oxygenation and ventilation without a significant leak. Timepoint: After device insertion, after induction to general anaesthesia.

Secondary outcome measures

1. Number of attempts (maximum three allowed). Timepoint: after induction to general anaesthesia
2. Oropharyngeal seal (leak) pressure (cmH20, maximum 40 cmH20). Timepoint: measured after insertion, at 30, 60 mins.
3. Insertion time (sec), measured from inserting the device between the teeth until connection to the anaesthetic machine. Timepoint: after induction to general anaesthesia.
4. Subjective assessment of insertion ease, measured using a 1-5 Likert scale. Timepoint: after insertion of the device.
5. Fiberoptic assessment of the device position, measured using a scale 1-4 (1- full view of the vocal cords, 2- partial view of the vocal cords only, 3- only epiglottis visible, 4- not even epiglottis visible). Timepoint: after device insertion. Note: this secondary outcome is eligible, it depends on the availability of flexible bronchoscope.
6. Insertion of the gastric tube measured using a 1-5 Likert scale. Timepoint: after insertion of the device. Note: this secondary outcome is eligible, it depends on clinical indication.
7. Perioperative complications – blood on the device, gastric contents inside the bowl, clinical signs of aspiration, laryngospasm, bronchospasm. Timepoint: at the end of the procedure, after the i-gel Plus removal.
8. Postoperative complications:
8.1. Sore throat (1-10 scale)
8.2. Pain on swallowing, swallowing difficulties (1-10 scale)
8.3. Hoarseness (1-10 scale)
8.4. Numb tongue, numbness inside the oral cavity (1-10 scale)
8.5. Cough
8.6. Neck pain (1-10 scale)
8.7. Jaw pain (1-10 scale)
Timepoint: Measured by questionnaire at 1 and 24 hours post-procedure. Selected patients showing significant complaints at 24 hours will be contacted by telephone at 3 and 6 months after the procedure.

Overall trial start date

01/09/2019

Overall trial end date

30/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Males or females
2. Age 18-89 years
3. American Society of Anesthesiologists classification (ASA) I-III status
4. Elective procedure without a need for muscle relaxation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

1. Age less than 18 or more than 89 years
2. American Society of Anesthesiologists classification (ASA) more than III status
3. Emergency surgery
4. Intra-abdominal operations, intrathoracic procedures
5. Increased risk for aspiration of gastric contents
6. BMI of more than 35 kg/m2
7. Unusual operating positioning – steep head down, prone, sitting
8. Incapacity to understand/sign informed consent (learning difficulties, language difficulties)

Recruitment start date

01/01/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

Czech Republic, Poland, Switzerland, United Kingdom

Trial participating centre

Vseobecna fakultni nemocnice v Praze (General University Hospital in Prague)
U nemocnice 2
Prague
12808
Czech Republic

Trial participating centre

Fakultni nemocnice Olomouc (University Hospital in Olomouc)
I.P. Pavlova 185/6
Olomouc
77900
Czech Republic

Trial participating centre

Barlicki University Hospital in Lodz
Kopcinskiego 22
Lodz
PL91-153
Poland

Trial participating centre

Inselspital Bern
Freiburgstrasse 18
Bern
3010
Switzerland

Trial participating centre

Antrim Area Hospital, Northern HSC Trust
Bush Road
Antrim
BT41 2RL
United Kingdom

Trial participating centre

Craigavon Area Hospital, Southern HSC Trust
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom

Sponsor information

Organisation

Vseobecna fakultni nemocnice (General University Hospital)

Sponsor details

U nemocnice 2
Prague
12028
Czech Republic
+420 (0)224962243
jan.blaha@vfn.cz

Sponsor type

Hospital/treatment centre

Website

https://www.vfn.cz/

Funders

Funder type

Government

Funder name

Czech Ministry of Health MZCZ-DRO-VFN64165

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Publication of the protocol: BMC Anesthesiology 03/2020
2. Presentation of the results: anaesthetic conference in 2021
3. Publication of raw data 07/2021 - www.mendeley.com
4. Publication: anaesthetic journal with an Impact Factor, submission 12/2021

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository Mendeley (https://data.mendeley.com). Type of data that will be shared: raw data, anonymized, demographics: gender, age, height, weight, BMI, procedure, duration; insertion parameters (as stated in the primary and secondary outcomes for the study), postoperative complications. When the data will become available, and for how long: after completion of the study, permanently. By what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism, whether consent from participants was obtained, comments on data anonymisation, any ethical or legal restrictions, any other comments: publicly available data, availability for everybody - secondary statistical analysis, systematic reviews, meta-analysis, consent from participants obtained for publishing of anonymized raw data, data anonymized according to the GDPR legal regulations in the Czech Republic and EU, no other ethical/legal regulations).

Intention to publish date

01/12/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/11/2019: Trial's existence confirmed by Ethics Committee of the General University Hospital in Prague.