Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Evaluation of the insertion parameters and complications of the i-gel Plus airway device for maintaining patent airway during planned procedures under general anaesthesia: a protocol for a prospective multicentre cohort study

O. Klementova, TK. Bhoday, J. Werner, AM. Lopez, W. Donaldson, E. Lichnovsky, T. Gaszyński, T. Henlin, J. Bruthans, J. Ulrichova, M. Lukes, J. Blaha, M. Kral, L. Gomez, R. Berge, J. Holland, F. McAleavey, S. Arava, L. Merjava Skripecka, S....

. 2021 ; 11 (12) : e053215. [pub] 20211220

Jazyk angličtina Země Velká Británie

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22011670

INTRODUCTION: Supraglottic airway devices represent a less invasive method of airway management than tracheal intubation during general anaesthesia. Their continued development is focused mainly on improvements in the insertion success rate and minimalisation of perioperative and postoperative complications. The i-gel Plus is a novel, anatomically preshaped supraglottic airway device which achieves a perilaryngeal seal due to a non-inflatable cuff made of a soft thermoplastic elastomer. The purpose of this cohort study is to assess the success rate of the i-gel Plus use during elective procedures under general anaesthesia, its intraoperative performance, and the degree of postoperative complications. METHODS AND ANALYSIS: This is a multicentre, prospective, interventional cohort study. The enrolment will take place in seven centres in four European countries. We plan to enrol 2000 adult patients in total, who are scheduled for elective surgery under general anaesthesia, and with an indication for use of a supraglottic airway device for management of their airway. The study is projected to run over a period of 18 months. The primary outcome of the study is the total success rate of the i-gel Plus insertion in terms of successful ventilation and oxygenation through the device. Secondary outcomes include perioperative parameters, such as insertion time, seal/leak pressures, number of insertion attempts and postoperative adverse events and complications. Postoperative follow-up will be performed at 1 hour, 24 hours in all patients, and for selected patients at 3 and 6 months. ETHICS AND DISSEMINATION: The cohort study has received the following ethical approvals: General University Hospital Prague, University Hospital Olomouc, University Military Hospital Prague, University Hospital Barcelona, University Hospital Lodz, Antrim Area Hospital, Craigavon Area Hospital, Office for Research Ethics Committees Northern Ireland. The results will be published in peer-reviewed journals and presented at relevant anaesthesia conferences. TRIAL REGISTRATION NUMBER: ISRCTN86233693;Pre-results.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22011670
003      
CZ-PrNML
005      
20220506131236.0
007      
ta
008      
220425s2021 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/bmjopen-2021-053215 $2 doi
035    __
$a (PubMed)34930740
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Klementova, Olga $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc, Olomouc, Czech Republic
245    10
$a Evaluation of the insertion parameters and complications of the i-gel Plus airway device for maintaining patent airway during planned procedures under general anaesthesia: a protocol for a prospective multicentre cohort study / $c O. Klementova, TK. Bhoday, J. Werner, AM. Lopez, W. Donaldson, E. Lichnovsky, T. Gaszyński, T. Henlin, J. Bruthans, J. Ulrichova, M. Lukes, J. Blaha, M. Kral, L. Gomez, R. Berge, J. Holland, F. McAleavey, S. Arava, L. Merjava Skripecka, S. Sobczyk, T. Tyll, P. Michalek
520    9_
$a INTRODUCTION: Supraglottic airway devices represent a less invasive method of airway management than tracheal intubation during general anaesthesia. Their continued development is focused mainly on improvements in the insertion success rate and minimalisation of perioperative and postoperative complications. The i-gel Plus is a novel, anatomically preshaped supraglottic airway device which achieves a perilaryngeal seal due to a non-inflatable cuff made of a soft thermoplastic elastomer. The purpose of this cohort study is to assess the success rate of the i-gel Plus use during elective procedures under general anaesthesia, its intraoperative performance, and the degree of postoperative complications. METHODS AND ANALYSIS: This is a multicentre, prospective, interventional cohort study. The enrolment will take place in seven centres in four European countries. We plan to enrol 2000 adult patients in total, who are scheduled for elective surgery under general anaesthesia, and with an indication for use of a supraglottic airway device for management of their airway. The study is projected to run over a period of 18 months. The primary outcome of the study is the total success rate of the i-gel Plus insertion in terms of successful ventilation and oxygenation through the device. Secondary outcomes include perioperative parameters, such as insertion time, seal/leak pressures, number of insertion attempts and postoperative adverse events and complications. Postoperative follow-up will be performed at 1 hour, 24 hours in all patients, and for selected patients at 3 and 6 months. ETHICS AND DISSEMINATION: The cohort study has received the following ethical approvals: General University Hospital Prague, University Hospital Olomouc, University Military Hospital Prague, University Hospital Barcelona, University Hospital Lodz, Antrim Area Hospital, Craigavon Area Hospital, Office for Research Ethics Committees Northern Ireland. The results will be published in peer-reviewed journals and presented at relevant anaesthesia conferences. TRIAL REGISTRATION NUMBER: ISRCTN86233693;Pre-results.
650    _2
$a dospělí $7 D000328
650    _2
$a zajištění dýchacích cest $x metody $7 D058109
650    12
$a celková anestezie $x škodlivé účinky $7 D000768
650    _2
$a kohortové studie $7 D015331
650    _2
$a lidé $7 D006801
650    _2
$a intratracheální intubace $x metody $7 D007442
650    12
$a laryngální masky $x škodlivé účinky $7 D017214
650    _2
$a multicentrické studie jako téma $7 D015337
650    _2
$a prospektivní studie $7 D011446
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Bhoday, Taranpreet Kaur $u Department of Anesthesiology and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic
700    1_
$a Werner, Jakub $u Department of Anesthesiology and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic
700    1_
$a Lopez, Ana M $u Department of Anesthesia, Hospital Clinic de Barcelona, Barcelona, Spain
700    1_
$a Donaldson, Will $u Department of Anaesthesia, Antrim Area Hospital, Antrim, UK
700    1_
$a Lichnovsky, Erik $u Department of Anaesthesia, Craigavon Area Hospital, Portadown, UK
700    1_
$a Gaszyński, Tomasz $u Department of Anaesthesiology and Intensive Therapy, Medical University of Lodz, Lodz, Poland
700    1_
$a Henlin, Tomas $u Department of Anesthesia and Intensive Medicine, Military University Hospital Prague, Praha, Czech Republic
700    1_
$a Bruthans, Jan $u Department of Anesthesiology and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic
700    1_
$a Ulrichova, Jitka $u Department of Anesthesiology and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic
700    1_
$a Lukes, Martin $u Department of Anesthesiology and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic
700    1_
$a Blaha, Jan $u Department of Anesthesiology and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic
700    1_
$a Kral, Michal $u Department of Anesthesiology and Intensive Medicine, University Hospital Olomouc, Olomouc, Czech Republic
700    1_
$a Gomez, Lidia $u Department of Anesthesia, Hospital Clinic de Barcelona, Barcelona, Spain
700    1_
$a Berge, Raquel $u Department of Anesthesia, Hospital Clinic de Barcelona, Barcelona, Spain
700    1_
$a Holland, Jonathan $u Department of Anaesthesia, Antrim Area Hospital, Antrim, UK
700    1_
$a McAleavey, Francis $u Department of Anaesthesia, Antrim Area Hospital, Antrim, UK
700    1_
$a Arava, Shiva $u Department of Anaesthesia, Craigavon Area Hospital, Portadown, UK
700    1_
$a Merjava Skripecka, Lubica $u Department of Anaesthesia, Craigavon Area Hospital, Portadown, UK
700    1_
$a Sobczyk, Sebastian $u Department of Anesthesiology and Intensive Therapy, Medical University of Lodz, Lodz, Poland
700    1_
$a Tyll, Tomas $u Department of Anesthesia and Intensive Medicine, Military University Hospital Prague, Praha, Czech Republic
700    1_
$a Michalek, Pavel $u Anaesthesia and Intensive Medicine, General University Hospital in Prague, Praha, Czech Republic pavel.michalek@vfn.cz $1 https://orcid.org/0000000181195927 $7 xx0079908
773    0_
$w MED00184484 $t BMJ open $x 2044-6055 $g Roč. 11, č. 12 (2021), s. e053215
856    41
$u https://pubmed.ncbi.nlm.nih.gov/34930740 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220425 $b ABA008
991    __
$a 20220506131228 $b ABA008
999    __
$a ok $b bmc $g 1789329 $s 1162868
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2021 $b 11 $c 12 $d e053215 $e 20211220 $i 2044-6055 $m BMJ open $n BMJ Open $x MED00184484
LZP    __
$a Pubmed-20220425
Zpět

Najít záznam

Citační ukazatele

Možnosti archivace