The evaluation of the insertion parameters and complications of the i-gel Plus airway device for maintaining patent airway during planned procedures under general anaesthesia
| ISRCTN | ISRCTN86233693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86233693 |
| Secondary identifying numbers | U1111-1244-3085 |
- Submission date
- 26/11/2019
- Registration date
- 16/12/2019
- Last edited
- 21/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
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 seven centres across Europe - three in the Czech Republic (two in Prague, one in Olomouc), one in Poland (Lodz), one in Switzerland (Bern), one in Spain (Barcelona), two in the United Kingdom (Antrim, Craigavon). The lead centre is the General University Hospital in Prague, Czech Republic.
When is the study starting and how long is it expected to run for?
September 2019 to December 2025
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
Contact information
Scientific
Department of Anaesthesia and Intensive Medicine
General University Hospital in Prague
Prague
12028
Czech Republic
 ORCID ID |
0000-0001-8119-5927 |
|---|---|
| Phone | +420 (0)224962666 |
| pavel.michalek@vfn.cz |
Public
Department of Anaesthesia and Intensive Medicine
General University Hospital in Prague
Prague
12028
Czech Republic
| Phone | +420 (0)224962243 |
|---|---|
| jakub.werner@vfn.cz |
Study information
| Study design | Multicentre interventional prospective cohort study. No control |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A prospective evaluation of the i-gel Plus supraglottic airway device in elective procedures |
| Study 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(s) | 1. 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 2. Approved 10/02/2020, University Hospital Olomouc (Etická komise FN a LF UP Olomouc, I. P. Pavlova 185/6, 779 00 Olomouc, Czech Republic; +420 (0) 588 442 477; iveta.sudolska@fnol.cz), ref: 18/20 3. Approved 03/03/2020, University Hospital in Lodz (Komisja Bioetyczna przy Uniwersytecie Medycznym w Łodzi, Pl. Hallera 1B II piętro pok. 230, 90-647 Łódź, Poland; +48 (0) (42) 272-52-43, (42) 272-52-44, 785-911-596; bioetyka@umed.lodz.pl), ref: RNN/61/20/KE 4. Approved 08/09/2020, University Hospital in Barcelona (Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona, Hospital Clínic De Barcelona Villarroel, 170 – 08036 Barcelona, Spain; +34 (0)932275766; ceic@clinic.cat), ref: HCB 2020/0771 5. Approved 10/12/2020, Northern HSC Trust for Antrim Area Hospital in Antrim (Research and Development Office, Governance Department, Bush House, Antrim Area Hospital, Bush Road, , BT41 2QB, Northern Ireland; +44 (0)28 9442 4653; frances.johnston@northerntrust.hscni.net), ref: NT20-278410-10 6. Approved 22/04/2021, Southern HSC Trust for Craigavon Area Hospital (Research and Development Office, Southern Health & Social Care Trust, Ramone Building, Craigavon Area Hospital, 68 Lurgan Road, Portadown, BT63 5QQ, Northern Ireland; +44 (0)28 3861 4274; research.office@southerntrust.hscni.net), ref: ST2021/31 7. Approved 27/11/2020, Office for Research and Ethical Committee Northern Ireland (ORECNI; 5 Rathdown Walk, Lisburn BT28 2RF, United Kingdom/Northern Ireland; +44 (0)28 9536 1400; info.orecni@hscni.net), ref: REC 20/NI/0140 8. Approved 21/12/2020, University Military Hospital in Prague (Etická komise Ústřední vojenské nemocnice – Vojenské fakultní nemocnice Praha, U Vojenské nemocnice 1200, 169 02 Praha 6, Czech Republic; +420 (0)973 203 550; nina.vesela@uvn.cz), ref: 108/15-104/2020 |
| 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 | Procedure/Surgery |
| 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 study start date | 01/09/2019 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 89 Years |
| Sex | Both |
| Target number of participants | 2000 |
| 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 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 | 23/09/2020 |
| Recruitment end date | 31/05/2025 |
Locations
Countries of recruitment
- Czech Republic
- Northern Ireland
- Poland
- Spain
- United Kingdom
Study participating centres
Prague
12808
Czech Republic
Olomouc
77900
Czech Republic
Lodz
PL91-153
Poland
Antrim
BT41 2RL
United Kingdom
Portadown
BT63 5QQ
United Kingdom
Prague
16902
Czech Republic
Barcelona
170 08036
Spain
Sponsor information
Hospital/treatment centre
U nemocnice 2
Prague
12028
Czech Republic
| Phone | +420 (0)224962243 |
|---|---|
| jan.blaha@vfn.cz | |
| Website | https://www.vfn.cz/ |
"ROR" |
https://ror.org/04yg23125 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 24/09/2021: 1. Publication of the protocol: BMC Anesthesiology or BMJ Open 12/2021 2. Presentation of the results: anaesthetic conference in 2023 3. Publication of raw data 07/2023 - https://www.mendeley.com 4. Publication: anaesthetic journal with an Impact Factor, submission 12/2023 Previous publication and dissemination plan from 16/10/2020 to 24/09/2021: 1. Publication of the protocol: BMC Anesthesiology or BMJ Open 12/2021 2. Presentation of the results: anaesthetic conference in 2022 3. Publication of raw data 07/2022 - https://www.mendeley.com 4. Publication: anaesthetic journal with an Impact Factor, submission 12/2022 Original 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 - https://www.mendeley.com 4. Publication: anaesthetic journal with an Impact Factor, submission 12/2021 |
| IPD sharing plan | 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 the publishing of anonymized raw data, data anonymized according to the GDPR legal regulations in the Czech Republic and EU, no other ethical/legal regulations). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 22/07/2021 | 24/09/2021 | No | No | |
| Protocol article | 20/12/2021 | 22/12/2021 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
21/01/2025: The following changes have been made:
1. The recruitment end date was changed from 30/11/2024 to 31/05/2025.
2. The overall study end date was changed from 31/12/2024 to 31/12/2025.
3. The intention to publish date was changed from 01/06/2025 to 01/06/2026.
01/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 30/11/2024.
2. The overall trial end date was changed from 30/03/2023 to 31/12/2024 and the plain English summary updated accordingly.
3. The intention to publish date was changed from 01/12/2023 to 01/06/2025.
22/12/2021: Publication reference added.
29/09/2021: Ethics approval details added.
24/09/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2022 to 28/02/2023.
2. The overall trial end date was changed from 30/03/2022 to 30/03/2023.
3. The intention to publish date was changed from 01/12/2022 to 01/12/2023.
4. The publication and dissemination plan was updated.
5. Ethics approval details added.
6. Publication reference added.
16/10/2020: The following changes were made to the trial record:
1. Inselspital Bern was removed as a trial participating centre and Switzerland was removed as a country of recruitment.
2. Central Military Hospital/Military University Hospital in Prague, University Hospital in Barcelona were added as trial participating centres and Spain was added as a country of recruitment.
2. The recruitment start date was changed from 01/09/2020 to 23/09/2020.
3. The recruitment end date was changed from 28/02/2021 to 28/02/2022.
4. The overall trial end date was changed from 30/03/2021 to 30/03/2022.
5. The IPD sharing statement was updated.
6. The intention to publish date was changed from 01/12/2021 to 01/12/2022.
01/05/2020: The recruitment start date was changed from 01/01/2020 to 01/09/2020.
29/11/2019: Trial's existence confirmed by the Ethics Committee of the General University Hospital in Prague.
