Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000788774
Ethics application status
Approved
Date submitted
12/07/2013
Date registered
15/07/2013
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tracheal Intubation Confirmation- A New Technique
Scientific title
Efficacy of Farrukh Airway Swing Test in confirmation of tracheal/esophageal intubation in patients requiring oral endotracheal anaesthesia
Secondary ID [1] 282742 0
nil
Universal Trial Number (UTN)
U1111-1145-0676
Trial acronym
Farrukh Airway Swing Test (FAST)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
confirmation of tracheal intubation/esophageal intubation 289477 0
Condition category
Condition code
Anaesthesiology 289797 289797 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tracheal and esophageal intubations in randomised patients requiring general orotracheal anaesthesia to elicit Farrukh Airway Swing Test.
Description of intervention (FAST Maneuver)
After the patient is anaesthetized and paralysed with a neuromuscular blocker, the physician(operator) performs lyrangoscopy and intubates the trachea. Withount moving the larygoscope or inflating the tracheal cuff, the operator ,with the flick of middle finger of the right hand (free hand) displaces the thyroid cartilage towards right. The tracheal tube swings back towards left and touches the thumb of the left hand holding the laryngoscope. This swing creates an angle of 30 degrees to 90 degrees from horizontal direction in the line of angle of mouth . The movement of the tracheal tube is smooth and in one direction.
In case the tube is not in trachea but in esophagus ,When the thyroid cartilage is displaced with the flick of the middle finger of the right hand, the ETT does not swing back but it sluggishly rises 10-20 degrees and falls back. Some times it does not rise at all.
The observer can clearly differentiate that the ETT is endo tracheal or in esophagus.
Capnography will be used as a gold standard in this trial for the confirmation of tracheal intubation. Farrukh Airway Swing Test will be assassed for senstivity and specificity against capnography for the confirmation of tracheal intubation.
Positivity criterion
The ETT touches the thumb of the hand holding the laryngoscope or swings to an angle 30 degrees to 90 degrees when the thyroid cartilage is flicked.

Approximate duration of FAST (Test)

One to two seconds
Intervention code [1] 287469 0
Diagnosis / Prognosis
Comparator / control treatment
Patients in Group A ( control)in whom tracheal intubation will be performed and the test elicited .
In the intervention group (Group B), oesophageal intubation will be done and the test elicited.
The ability of the blinded observer to differentiate between tracheal or oesophageal intubation after eliciting the FAST will determine the efficacy of FAST against gold standard i.e capnography.
Control group
Active

Outcomes
Primary outcome [1] 289943 0
sensitivity and specificity of Farrukh Airway Swing Test for confirmation of tracheal intubation.After the FAST is elicited and the observer detects it as tracheal intubation, it is further confirmed by end tidal capnography as true positive. So end tidal capnography is the standard tool against which the sensitivity and specificity of Fast will be assessed.
True Positive (TP) will be the patients with ETT in trachea as confirmed by end tidal capnography who will be correctly identified as tracheal intubation by the new test.(FAST)
False positive( FP) will be patients with oesophageal intubation as done under direct vision by the operator who will be falsely labelled as tracheal by the observer. After eliciting the test they will be tracheally intubated and confirmed by capnography.
True Negative (TN )will be the patients in whom oesophageal intubation will be performed under direct vision by the operator who will be correctly identified as oesophageal by the test .
False Negative (FN) will be the patients with ETT in trachea as confirmed by end tidal capnography who will be falsely identified as oesophageal intubation by the new test.(FAST)
sensitivity,specificity, positive predictive value and negative predictive value of FAST will be calculated
Timepoint [1] 289943 0
After tracheal/esophageal intubation and eliciting of Farrukh Airway Swing Test
Secondary outcome [1] 303628 0
Non-dependance on endtidal carbon dioxide for confirmation of tracheal intubation
Timepoint [1] 303628 0
After tracheal/esophageal intubation
Secondary outcome [2] 303629 0
A decreased time to detection of esophageal intubation, utilizing Farrukh Airway Swing Test, will allow for the re-positioning of the tracheal tube in the trachea during the same laryngoscopy. This will save precious time in hypoxaemic conditions.
Timepoint [2] 303629 0
After tracheal/esophageal intubation

Eligibility
Key inclusion criteria
Patients of either gender undergoing elective surgery under general anaesthesia requiring orotracheal intubation .The patients in both the groups will be ASA1, Mallampatti 1and on laryngoscopy Cormack and Lehan grade 1`
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- patients with chances of vomiting or regurgitation, 2 -patients with respiratory or cardiovascular or any other illness not permitting laryngoscopy for more than 30 seconds.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For Group A-(control ),the patients will be randomly enrolled
from the operation list according to the inclusion and exclusion criteria.
For Group B-(study Group)- patient volunteers will be enrolled randomly during the pre anaesthesia visit according to the set criteria for inclusion .
Informed consent for participation in study will be obtained from all the patients.
For patient volunteers in Gp B, special in formed consent will be obtained . All the possible risks involved will be discussed and a video of the procedure will be shown at the time of taking the consent for participation as a patient volunteer.
The identities of all the participants will be concealed and each participant will be allocated a computer generated number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two sets of envelops will be provided.Each set will have computer generated ID developed at the time of enrollment for each participant. One envelop will have instructions for the operator and the second envelop will carry the instructions and response card for the assessor.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In order to get 95% confidence interval with absolute precision level of 0.15 and anticipated population proportion of 0.80 between the group A and B the sample size was calculated to be 55.Sensitivity,specificity,positive predictive value,negative predictive value of Farrukh Swing Test will be calculated for the diagnosis of tracheal intubation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2013
Actual
17/03/2014
Date of last participant enrolment
Anticipated
Actual
28/06/2014
Date of last data collection
Anticipated
Actual
28/06/2014
Sample size
Target
55
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 5168 0
Pakistan
State/province [1] 5168 0
Punjab

Funding & Sponsors
Funding source category [1] 287566 0
Self funded/Unfunded
Name [1] 287566 0
Brig Dr. Farrukh Mahmood Akhter
Country [1] 287566 0
Pakistan
Primary sponsor type
Individual
Name
Brig Dr. Farrukh Mahmood Akhter
Address
Dept. of Anaesthesia and Pain Management, Operation Theater, AFIU (Armed forces institute of urology),
CMH medical complex
Tameez uddin Road
Rawalpindi cantt
Post code 46000
Country
Pakistan
Secondary sponsor category [1] 286318 0
Individual
Name [1] 286318 0
Maj. Gen Mohammad Amjad Iqbal
Address [1] 286318 0
Head of Department
Dept. of Anaesthesia and Pain Management, Operation Theater,
CMH medical complex
Tameez uddin Road
Rawalpindi cantt
Post code 46000
Country [1] 286318 0
Pakistan
Other collaborator category [1] 277519 0
Individual
Name [1] 277519 0
Col Amar Mahmood Malak
Address [1] 277519 0
Dept. of Anaesthesia and Pain Management, Operation Theater, AFIU (Armed forces institute of urology),
CMH medical complex
Tameez uddin Road
Rawalpindi cantt
Post code 46000
Country [1] 277519 0
Pakistan
Other collaborator category [2] 280261 0
Individual
Name [2] 280261 0
Maj. Anjum Dilshad SafderMBBS,MCPS,FCPSConsultant Gynaecologist
Address [2] 280261 0
Dept. of Obstetrics and Gynaecology
Combined Military Hospital,Zia ul Haq Avenue,
Bahawalpur Cantt
Country [2] 280261 0
Pakistan
Other collaborator category [3] 280262 0
Individual
Name [3] 280262 0
Ammad FarrukhMedical student4th year MBBS
Address [3] 280262 0
Foundation university Medical College
DHA I Campus
Islamabad
Country [3] 280262 0
Pakistan
Other collaborator category [4] 280263 0
Individual
Name [4] 280263 0
Monira Abdul Rahman Al Shoshan
Address [4] 280263 0
Dept. of Anaesthetics, King Saud Hospital, King Abdullah Bin Abdul Aziz Road, Unaizah Al Qaseem,

PO Box 1036, Unaizah 51911
Country [4] 280263 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289539 0
AFIU/CMH Medical complex ethics committee
Ethics committee address [1] 289539 0
Ethics committee country [1] 289539 0
Pakistan
Date submitted for ethics approval [1] 289539 0
14/06/2013
Approval date [1] 289539 0
28/06/2013
Ethics approval number [1] 289539 0
AFIU/Anaes/101810

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41062 0
A/Prof Brig Farrukh Mahmood Akhter
Address 41062 0
Dept. of Anaesthesia and Pain Management, Operation Theater, AFIU (Armed forces institute of urology),
CMH medical complex
Tameez uddin Road

Rawalpindi cantt
Post code 46000
Country 41062 0
Pakistan
Phone 41062 0
+92 51 5564315,+92 3219555446
Fax 41062 0
Email 41062 0
[email protected]
Contact person for public queries
Name 41063 0
Brig Farrukh Mahmood Akhter
Address 41063 0
Dept. of Anaesthesia and Pain Management, Operation Theater, AFIU (Armed forces institute of urology),
CMH medical complex
Tameez uddin Road

Rawalpindi cantt
Post code 46000
Country 41063 0
Pakistan
Phone 41063 0
+92 51 5564315,+92 3219555446
Fax 41063 0
Email 41063 0
[email protected]
Contact person for scientific queries
Name 41064 0
Brig Farrukh Mahmood Akhter
Address 41064 0
Dept. of Anaesthesia and Pain Management, Operation Theater, AFIU (Armed forces institute of urology),
CMH medical complex
Tameez uddin Road

Rawalpindi cantt
Post code 46000
Country 41064 0
Pakistan
Phone 41064 0
+92 51 5564315,+92 3219555446
Fax 41064 0
Email 41064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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