Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201705002284531 Date of Approval: 11/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of deep vs awake laryngeal msak airway removal on airway complications in spontaneously breathing adult patients following Isoflurane gen anest
Official scientific title Impact of deep vs awake laryngeal msak airway removal on airway complications in spontaneously breathing adult patients following Isoflurane general anesthesia
Brief summary describing the background and objectives of the trial Background: The Laryngeal Mask Airway (LMA) is one of several supra-glottic airway management devices used in anesthesia .The scope of use of the LMA is progressively expanding to areas previously contraindicated, for instance laparoscopy and prone position surgery. Certain aspects of LMA use remain unsettled. Whether to remove the LMA when a patient is ¿awake¿ vs ¿deep¿ following anesthesia is one such area. The manufacturer Ambu® recommends that the AuraOnce¿ LMA be removed once the patient is fully awake and protective airway reflexes are active. Despite this, several studies have shown benefit in removal of the LMA while a patient is ¿deep¿ in the pediatric population. Current evidence is inconclusive as to which approach is preferable and safer in adults. Objectives Primary Objective: To compare the impact of having LMA removal deep versus awake on the occurrence of airway complications following general anaesthesia in spontaneously breathing adult patients. Secondary Objective: To compare the impact of deep versus awake LMA removal on anaesthesia theater turn around time.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial compare the impact of having LMA removal deep versus awake on the occurrence of airway complications
Anticipated trial start date 01/02/2017
Actual trial start date 30/05/2017
Anticipated date of last follow up 30/05/2017
Actual Last follow-up date 30/05/2017
Anticipated target sample size (number of participants) 116
Actual target sample size (number of participants) 116
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Awake arm LMA removal while awake 58 Active-Treatment of Control Group
Experimental Group Deep arm Laryngeal mask airway removed at minimum alveolar concentration Isoflurane of 1.15% 58
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ All ASA I and II patients between 18 years- 65 years scheduled to receive general anesthesia with a laryngeal mask airway (as the airway management device) for elective surgery. ¿ Active history of upper and or lower respiratory tract infection/disease ¿ Patients with a difficult LMA insertion (defined as greater than two attempts) ¿ Patients with severe gastroesophageal reflux disease ¿ Patients with a symptomatic hiatus hernia ¿ Patients with a BMI> 40kg/m2 ¿ History of Obstructive sleep apnoea ¿ Patients in whom muscle relaxants is to be/ is used ¿ Patients with Mallampati class 3 and 4 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/01/2017 Research Ethics Committee Aga Khan University Hospital Nairobi
Ethics Committee Address
Street address City Postal code Country
Aga Khan University Hospital Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ To compare the impact of having LMA removal deep versus awake on the occurrence of airway complications following general anaesthesia in spontaneously breathing adults patients. End of surgery, on attaining an Isoflurane endtidal of 1.15 for deep arm End of surgey on attaining end tidal Isoflurane of < 0.5 (and/or ) an appropriate response to command( in this case - mouth opening ) for Awake arm
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University hospital Nairobi Kenya PO BOX 30270 3rd Parklands Avenue Nairobi Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital Nairobi P.O.Box 30270 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Hospital Nairobi P.O.Box 30270 Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Aga Khan University Hospital Nairobi P.O.Box 30270 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David nekyon david.nekyon@aku.edu +254721380580 P.O.Box 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya anaesthesia department Chair
Role Name Email Phone Street address
Public Enquiries Research Support Unit research.supportea@aku.edu 020-3662148 P.O.Box 30270
City Postal code Country Position/Affiliation
00100 Kenya Research support unit
Role Name Email Phone Street address
Scientific Enquiries Ronald Ombaka ronombaka@gmail.com +254711410 932 P.O. Box 35235
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information