CTRI Number |
CTRI/2020/11/028984 [Registered on: 09/11/2020] Trial Registered Prospectively |
Last Modified On: |
15/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Surgical/Anesthesia Other (Specify) [Airtraq DL] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of 2 types of laryngoscopes (Airtraq and Mcintosh) for inserting double lume endotracheal tubes(A special type of endotracheal tube used in lung surgeries for oxygenation during anaesthesia)in airways which are intentionally made difficult |
Scientific Title of Study
|
Comparison of Airtraq and Mc intosh laryngoscope for double lumen tube intubation in simulated difficult airway.- A randomised study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
K Mounika |
Designation |
Post graduate student |
Affiliation |
Nizams institute of Medical sciences |
Address |
Staff Anaesthesia room,Millenium Block cardiothoracic surgery operation theatre ,Department of Anaesthesia,
Nizams institute of Medical sciences
Hyderabad
Hyderabad TELANGANA 500082 India |
Phone |
|
Fax |
|
Email |
2018mounika.k@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prachi Kar |
Designation |
Associate Professor |
Affiliation |
Nizams institute of Medical sciences |
Address |
Staff Anaesthesia room, Millenium Block Cardiothoracic surgery operation theatre,Department of Anaesthesia,
Nizams institute of Medical sciences
Hyderabad
Hyderabad TELANGANA 500082 India |
Phone |
7702897765 |
Fax |
|
Email |
prachikar@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
K Mounika |
Designation |
Post graduate student |
Affiliation |
Nizams institute of Medical sciences |
Address |
Staff Anaesthesia room, Millenium Block Cardiothoracic surgery Operation Theatre,Department of Anaesthesia,
Nizams institute of Medical sciences
Hyderabad
Hyderabad TELANGANA 500082 India |
Phone |
|
Fax |
|
Email |
2018mounika.k@gmail.com |
|
Source of Monetary or Material Support
|
Nizams institute of Medical sciences, Hyderabad, Telangana |
|
Primary Sponsor
|
Name |
K Mounika |
Address |
Department of Anaesthesia
Nizams Institute of Medical Sciences, Hyderabad |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Prachi Kar |
Associate Professor, Nizams Institute of Medical Sciences, Hyderabad |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
K Mounika |
Nizams institute of medical sciences |
Staff Anaesthesia room, Millenium Block Cardiothoracic surgery Operation Theatre. Depart of Anaesthesia Hyderabad TELANGANA |
8885283618
2018mounika.k@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
NIMS Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Airtraq laryngoscope |
Airtraq Dl laryngoscope for Double lumen tube insertion in simulated difficult airway. |
Comparator Agent |
Mc Intosh Laryngoscope |
Mc Intosh Laryngoscope for Double lumen tube insertion in simulated difficult airway |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA I or II, Age 18 - 60 years, both sex, patients with normal airway parameters |
|
ExclusionCriteria |
Details |
Anticipated difficult intubation or difficult mask ventilation parameters
Patients with large thyroid mass or other neck masses
C-spine fracture or other cervical disorders with restricted neck movement or unstable cervical spine
faciomaxillary injury or anomalies, Abnormalities of airway like burn contractures and cleft lip/palate
TMJ ankyloses
patient with bleeding disorders
uncontrolled hypertension,
Actively secreting adrenal tumours, or cardiac disorders where hemodynamic response to intubation may not be well tolerated
BMI>30
Pregnant females |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time required for DLT insertion |
Time required for DLT insertion |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. The number of attempts at intubations and failures if any
2. Cormack Lehanne grade and Intubation difficulty score
3. Ease of laryngoscopy and ease of intubation on 4-point Likert scale
4. The incidence of complications like trauma, desaturation, cuff rupture and postoperative sore throat
5- Hemodynamic response to intubation |
hemodynamic response at 1,2 and 5 minutes after intubation
compliationsafter intubation and in post operative period |
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/11/2020 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
after study completion |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Written informed consent will be obtained from the subjects recruited for this single blinded randomised study. Patient’s age, height, weight, ASA/NYHA status, diagnosis, surgery, co morbidities and airway parameters {(Inter incisor gap (IID), Mentohyoid distance (MHD), Thyromental distance (TMD), Sternomental distance (SMD), Malampatti grading (MPG) } will be noted preoperatively. 52 patients with expected normal airway parameters will be randomly allocated to either the Airtraq or Macintosh group (group A and group M respectively), using computer generated randomisation chart . The patients will be premeditated with alprazolam 0.25 mg a night before the surgery and will be asked to follow NPO (Nil per oral) orders for 8h. After shifting the patients to the operating room, ASA standard monitoring along with entropy will be connected, 18G intravenous line will be placed and intravenous fluid will be started. Under strict aseptic precautions and local anaesthesia, radial artery will be cannulated with 20 G switch canula and arterial pressure will be monitored. Baseline mean arterial pressure (MAP), heart rate (HR), SpO2 values will be noted. Epidural space will be identified in T4-5/T5-6 interspace using 18G Tuohy needle with loss of resistance to air technique, epidural catheter will be inserted and test dose of 3ml, 2% lignocaine will be injected to rule out intrathecal position. Patients will be made to lie down in supine position with neutral neck position using a pad under the occiput and Philadelphia rigid cervical collar of appropriate size will be applied. Inter- incisor distance will be measured after collar application. Patients will be excluded if IID is <2 cm after collar application. The height of the operating table will be adjusted such that the plane of the patient’s face is at the level of xiphisternum of the anaesthesiologist performing laryngoscopy and intubation. Patients will be preoxygenated with 100 % Oxygen for 3 minutes followed by premedication with injection fentanyl 2ug/kg. Induction will be achieved with graded dose of propofol to achieve entropy of 40-60. After confirming ability to ventilate, inj. Rocuronium 1mg/kg will be administered and mask ventilation will be continued for one minute. At this point the sealed envelope containing the group allocation will be opened and the allocated laryngoscope will be made ready. In case of Airtraq, the stilette of DLT will be removed and the DLT will be preloaded into the integrated channel of Airtraq DL (ProdolMeditec S.A., Vizcaya, Spain) as per manufacturer instructions. Universal phone adapter will be used during intubation with Airtraq. The decision on the size of DLT to be used will be at the discretion of attending anaesthesiologist. The size of DLT used will be noted. During laryngoscopy the time to best glottic view will be noted. This will defined as time from beginning of laryngoscopy to obtain the best view of the vocal cords. Laryngoscopic view will be graded using Cormack lehane (CL) grading system and CL grade will be noted. Total time for intubation will be noted. This will be defined as time from beginning of laryngoscopy till successful completion of intubation. The length at which DLT is to be fixed at angle of mouth will be decided based on height-based formula {(height in cm /10) + 12} being approximated to nearest whole number. After placement of tube and inflation of cuff, the adequacy of isolation will be checked by auscultation. In patients where a failure to intubate or achieve isolation is encountered, Philadelphia collar will be removed and routine intubation practice will be followed for placement of DLT. Other parameters such as number of attempts, manoeuvres used for intubation, intubation difficulty according to intubation difficulty score (IDS) will be noted. The hemodynamic response to intubation (MAP and HR) at 1, 2 and 5 minutes after intubation will be noted. The ease of laryngoscopy and ease of tube placement will be noted on a 4-point Likert scale. Complications like oropharyngeal trauma, cuff rupture, desaturation will be noted. The patients will be followed up on the incidence of postoperative hoarseness. |