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

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2020/11/028984

Lead Sponsor: K Mounika

Brief Summary: Written informed consent will be obtained from the subjects recruited for this single blinded randomised study. Patientâ€™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 patientâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 52

Inclusion Criteria

ASA I or II, Age 18.
60 years, both sex, patients with normal airway parameters.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time required for DLT insertion	Time required for DLT insertion

Secondary Outcome Measures

Name	Time	Method
1.The number of attempts at intubations and failures if any	2.Cormack Lehanne grade and Intubation difficulty score

Trial Locations

Locations (1): Nizams institute of medical sciences
🇮🇳
Hyderabad, TELANGANA, India
Nizams institute of medical sciences
🇮🇳Hyderabad, TELANGANA, India
K Mounika
Principal investigator
8885283618
2018mounika.k@gmail.com