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.: PACTR201802003066353 Date of Approval: 09/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Accuracy of Bedside Upper Airway Ultrasonography versus Standard Auscultation for assuring the location of Endotracheal Tube after tracheal intubation
Official scientific title Accuracy of Bedside Upper Airway Ultrasonography versus Standard Auscultation for assuring the location of Endotracheal Tube after tracheal intubation: Comparative Study controlled by Quantitative Waveform Capnography
Brief summary describing the background and objectives of the trial Objectives: To assess accuracy and rapidity of bed-side upper airway ultrasonography (UA-US) versus standard auscultation (SA) for determination of endotracheal tube (ETT) position. Patients & Methods: 107 patients underwent tracheal intubation for maintenance of general anesthesia. Position of ETT was determined by chest auscultation for the presence of breath sounds on both sides, and by UA-US using 9¿12 MHz linear US transducer that was placed transversely on the neck anteriorly and superior to the suprasternal notch to visualize the ETT in the tracheal longitudinal and transverse views. Obtained data were compared to findings on using waveform capnography (WC). Time to define ETT position was determined. Study outcomes included diagnosis of ETT position; tracheal or esophageal, accuracy of diagnosis and time consumed till approaching the diagnosis
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied tracheal intubation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/02/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date 01/08/2018
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 126
Recruitment status Not yet recruiting
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I,tracheal intubation: controlled by Quantitative Waveform Capnography Wave capnography is considered as a gold standard for endotracheal intubation position by detection of appropriate exhaled CO2 that must be more than 30 mmHg after at least 5 breath with atypical CO2 wave form 42
Experimental Group Group II tracheal intubation by bedside upper airway ultrasonography responsible for performing upper airway US (UA-US) to ascertain the position of ETT; tracheal or esophageal and time lapsed since probe positioning till giving a decision about the tube position was given is determined. UA-US was performed using SonoScape US machine (China). A 9¿12 MHz linear ultrasound transducer was placed transversely on the neck anteriorly and superior to the suprasternal notc 42
Experimental Group Group III tracheal intubation by standard auscultation auscultatory confirmation of ETT position by the presence of breath sounds sought on both sides by auscultation on the infra-clavicular and infra-axillary areas and were classified into definite, doubtful or absent. 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients of ASA grade I and II and were assigned for general anesthesia with endotracheal intubation Exclusion criteria included presence of severe neck trauma, neck mass, scar of previous neck surgery, anatomic neck distortion, limited neck extension, abnormal airway anatomy and obesity. Patients need emergency intubation or with high risk of aspiration and severe cardiac, pulmonary, hepatic, or renal disease were excluded from the study. 25 Year(s) 60 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 01/01/2018 aswan university
Ethics Committee Address
Street address City Postal code Country
el seel street aswan 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. The diagnosis of ETT position; tracheal or esophageal 2. The accuracy of diagnosis using either SA standard auscultatory method or UA-US in comparison to WC. 3. time consumed till approaching the diagnosis after tracheal intubation
Secondary Outcome time consumed till approaching the diagnosis and recording blood pressure and heart rate readings and O2 saturation immediately, 5-min and 15-min after intubation. After tracheal intubation was done
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Aswan umiversity el seel street aswan 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sherif kamal arafa el bahr street tanta 35127 Egypt
amir abozikary el sayed el seel street aswan 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal arafa el bahr street tanta 35127 Egypt Funding Agency
Secondary Sponsor amir abozikary el sayed el seel street aswan 35127 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa el bahr street tanta 35127 Egypt
amir abozikary el sayed el seel street aswan 35127 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
REPORTING
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