The i-gel Plus supraglottic airway represents the next generation of the i-gel device. The aim of this international multicentre prospective cohort study was to evaluate its performance in adult patients during elective procedures in various surgical disciplines under general anaesthesia. The primary outcome of the study was the overall success rate of insertion allowing effective airway management, ventilation, and oxygenation. The secondary outcomes included perioperative performance of the device and the incidence of postoperative adverse events. The data of the first 1000 patients from our study (455 males and 545 females) are presented. These patients were mostly operated on in the supine position (83.3%) with a minority of them being in the lateral or lithotomy positions. The overall success rate was 98.6%, with a first-attempt success rate of insertion of 88.1%. A significant difference between males and females was seen for the overall success rate, 97.4% vs. 99.6% (p=0.002) but not for the successful insertion on the first attempt (p=0.97) The mean oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor increasing the risk of first-attempt failure was low experience of the operator (p<0.001). The insertion of the device was rated by 80.3% as being either very easy or easy. Fibreoptic assessment through the i-gel Plus showed a full view of the vocal cords in 67.8% of patients, a partial view in 21.9% and a downfolded epiglottis in 9.4% of patients. A gastric tube was inserted in 11.2% of patients with a 99.1% success rate. Perioperative complications included desaturation below 85% in 0.6%, traces of blood on the device in 7.4%, laryngospasm in 0.5% and gastric contents inside the cuff in 0.2% of patients. There were no clinical signs of aspiration and a 0.1% incidence of bronchospasm. Severe postoperative sore throat was recorded in 1.4%, and long-term hoarse voice in 0.2% of patients. All patients with moderate and serious postoperative complaints are being followed up by phone at 3 and 6 months. The i-gel Plus seems to be an effective supraglottic airway device providing a high success rate of insertion, sufficient oropharyngeal seal pressure, and a reasonably low incidence of complications.

P Michalek received travel reimbursements from Instersurgical Ltd.

ISRCTN86233693

https://bmjopen.bmj.com/content/11/12/e053215.long

This trial is supported by the Czech Ministry of Health, grant no. MZCZ-DRO-VFN64165.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics Committee of the General University Hospital in Prague (study sponsor) in November 2019 (No. 1952/19 S-IV, received 14/11/2019, dr. J. Sedivy, Chair). The Czech Ministry of Health will act as a sponsor and partial founder via General University Hospital in Prague (grant number MZCZ-DRO-VFN64165). Following this initial approval, the ethical approvals from other centres were obtained: University Hospital Olomouc (No. 18/20, received 10/02/2020, Dr. J. Buresova, chair), University Hospital in Lodz (No. RNN/61/20/KE, received 03/03/2020, Prof. J. Drzewoski, chair), University Hospital in Barcelona (No. HCB 2020/0771, received 08/09/2020, Dr. A.L. Arellano Andrino, secretary), Northern HSC Trust for Antrim Area Hospital in Antrim (No. NT20-278410-10, received 10/12/2020, Dr. M. Rooney, Trust Director of Research and Development), Southern HSC Trust for Craigavon Area Hospital (No. ST2021/31, received 22/04/2021, Dr. P. Sharpe, Trust Director of Research and Development), Office for Research and Ethical Committee Northern Ireland (ORECNI) (REC 20/NI/0140, received 27/11/2020, Prof. P. Murphy, HSC REC B Chair), University Military Hospital in Prague (No. 108/15-104/2020, received 21/12/2020, Prof. J. Plas, chair).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

All data produced in the present study are available upon reasonable request to the authors