|- candidate number||14514|
|- NTR Number||NTR3901|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-mrt-2013|
|- Secondary IDs||U1111-1140-6101 |
|- Public Title||Comparison of placement techniques of proseal laryngeal mask.|
|- Scientific Title||Comparison of proseal laryngeal mask placement with the new knotted grip technique using gum elastic bougie versus three other standard techniques (digital technique and using introducer tool).|
|- hypothesis||The knotted grip placement technique of proseal laryngeal mask shall ease its placement in patients undergoing general anesthesia for elective surgeries.|
|- Healt Condition(s) or Problem(s) studied||Supraglottic airway device, General anesthesia|
|- Inclusion criteria||1. Patients who give informed consent;|
2. Patients of either sex with age ≥18;
3. ASA physical status I or II;
4. Patients undergoing General Anesthesia for elective ambulatory surgery and sutaible for supraglottic device placement.
|- Exclusion criteria||1. Predictors of or a history of difficult intubation;|
2. Immobilized cervical spine;
3. A history of uncontrolled gastroesophageal reflux or hiatus hernia;
4. Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-jul-2014|
|- Target number of participants||308|
|- Interventions||In Group KG, PLM placement was aided by the GEB in a knotted grip while the other three groups (D,IT,L) served as the control group for the PLM placement. |
In Group D, PLM was placed using digital technique.
In Group IT- PLM placement was done employing introducer tool.
In Group L- PLM was placed using a conventional laryngoscope and bougie.
|- Primary outcome||Successful placement of PLM in first two attempts or records it as failure. |
|- Secondary outcome||1. Time to place PLM in seconds (start of introduction to first adequate capnographic curve);|
2. Ease of placement of GT (Easy [E], Difficult [D] or Failed [F]);
3. On removal of the device, any visible evidence of blood on the PLM (Y= yes, N= no);
4. Pre-induction HR & MAP and at 1, 5 &10 min after insertion of device.
|- Timepoints||BP and Pulse Will Be monitored at 1, 5 &10 min after insertion of device. Blood on device will be checked on device removal.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Naresh Kaul|
|- CONTACT for SCIENTIFIC QUERIES|| Naresh Kaul|
|- Sponsor/Initiator ||Ministry of Health, Oman|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Oman|
|- Brief summary||This study is designed to evaluate wether proseal laryngeal mask placement with the knotted grip technique using gum elastic bougie easier and safer than the other currently used techniques.|
|- Main changes (audit trail)|
|- RECORD||13-mrt-2013 - 25-mrt-2013|