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Comparison of placement techniques of proseal laryngeal mask.


- candidate number14514
- NTR NumberNTR3901
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2013
- Secondary IDsU1111-1140-6101 
- Public TitleComparison of placement techniques of proseal laryngeal mask.
- Scientific TitleComparison 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).
- ACRONYM
- hypothesisThe 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) studiedSupraglottic airway device, General anesthesia
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate1-jul-2014
- Target number of participants308
- InterventionsIn 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 outcomeSuccessful placement of PLM in first two attempts or records it as failure.
- Secondary outcome1. 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.
- TimepointsBP 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Naresh Kaul
- CONTACT for SCIENTIFIC QUERIES Naresh Kaul
- Sponsor/Initiator Ministry of Health, Oman
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Oman
- PublicationsN/A
- Brief summaryThis 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)
- RECORD13-mrt-2013 - 25-mrt-2013


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