Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201408000828263 Date of Approval: 15/05/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A novel method using ultrasonography for predicting difficult intubation.
Official scientific title A novel method for preoperative airway assessment using airway ultrasonography
Brief summary describing the background and objectives of the trial There is a need for a specific, sensitive, easy and non invasive method by which we can predict difficulty of intubation. Ultrasonography, might be the right answer. Imaging of airway by ultrasonography may be a useful adjunct to clinical methods of bedside airway assessment. However, at the present time, there is limited published data on sonography of the airway. So, this study aims to introduce a novel method to recruit the use of ultrasonography in visualization of airway structures, using it in preoperative airway assessment, to determine the extent of difficulty of the airway
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Preoperative airway assessment,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/07/2011
Actual trial start date 15/08/2011
Anticipated date of last follow up 01/01/2014
Actual Last follow-up date 27/02/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasonographic airway examination using ultrasound to measure certain distances 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. patients undergoing any elective or emergency operation admitted in Suez Canal University Hospital. 2. All patients aged from 16 to 75 years 3. Patients who are planned to have general anesthesia with endotracheal intubation. 4.Both sexes. 1. Patients¿ refusal to participate in the study. 2. Any patient who cannot be put in sniffing position either due to deformity or due to cervical spine injury. 3. Any airway pathology like large thyroid tumors 4.Pregnancy 16 Year(s) 75 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 23/05/2011 Faculty of Medicine, Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluation of an ultrasonographic novel method for preoperative airway assessment Preoperative visit
Secondary Outcome Comparison between sensitivity & specificity of that method & those for Mallampati classification, thyro-mental distance, and combination of both predictive tools, as a tools for preoperative airway assessment. Preoperative and intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University hospital Ring Road Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Suez Canal University hospitals Ring Road Ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Ring Road Ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Emad El-Din Abdel-Ghaffar Ring Road Ismailia 41522 Egypt
Ezzat Mohamed El-Taher Ring Road Ismailia 41522 Egypt
Peter Emad Abd-Elwahab Ring Road Ismailia 41522 Egypt
Mohamed Refaat Habba Ring Road Ismailia 41522 Egypt
Ahmed Hamed El-Touny Ring Road Ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdel-Ghaffar mohamed_abdelghafa@med.suez.edu.eg 00201003179831 1 Abo Zir Elghaffary street
City Postal code Country Position/Affiliation
Ismailia 41516 Egypt Professor of Anesthesia and Intensive Care
Role Name Email Phone Street address
Public Enquiries Mohamed Abdel-Ghaffar mohamed_abdelghafa@med.suez.edu.eg 00201003179831 1 Abo Zir Elghaffary street
City Postal code Country Position/Affiliation
Ismailia 41516 Egypt Professor of Anesthesia and Intensive Care
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdel-Ghaffar mohamed_abdelghafa@med.suez.edu.eg 00201003179831 1 Abo Zir Elghaffary street
City Postal code Country Position/Affiliation
Ismailia 41516 Egypt Professor of Anesthesia and Intensive Care
REPORTING
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Result URL Hyperlinks
Changes to trial information