Evaluation of two different methods of video-laryngoscopy

Completed

• Conditions: Diseases of the ear and mastoid process, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (3) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (4) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (5) ICD-10 Condition: K55-K64||Other diseases of intestines,

• Registration Number: CTRI/2018/12/016611
• Lead Sponsor: University College of Medical Sciences

Brief Summary

**Studytitle**

Comparison of face-to-facetracheal intubation and conventional head-end tracheal intubation usingvideo-laryngoscope in adults.

**Rationale:**Endotrachealintubation is one of the basic procedures for securing the airway. Video-laryngoscopyis a reliable, faster and comfortable method of laryngoscopy and trachealintubation and is a good substitute for direct laryngoscopy especially indifficult airway management. Airtraq is a new intubation aid to facilitateintubation in patients with normal or difficult airways. Airtraq laryngoscopewith its video-assistance, can be used for endotracheal intubation by insertingthe device from any relative operator-to-patient position. Several intubationpositions have been described to facilitate intubation especially when there islimited access to the patient, including the straddling, inverse, face-to-face,ice-pick, claw-hammer and lying position.

The studies have shown that Airtraqvideo-laryngoscope is easier to use and when compared to other devices, successrate of face-to-face tracheal intubation with Airtraq is superior. However,very limited literature is available describing face-to-face tracheal intubationin patients and not enough work has been done comparing face-to-face andconventional head-end tracheal intubation using video-laryngoscope.

So, we plan to compare face-to-face trachealintubation and conventional head-end tracheal intubation using video-laryngoscopein adults with normal airway undergoing elective surgeries under generalanaesthesia.

 **Aim:** Tocompare face-to-face tracheal intubation and conventional head-end trachealintubation using video-laryngoscope in adult patients requiring trachealintubation.

 **Objectives:**

*Primaryobjective* is to know the time taken for successful trachealintubation.

*Secondary* *objectives* would be to know about the *Intubating conditions* such asdeviceInsertion time, glottic view according to POGO score and Cormack & Lehanegrading, ease of intubation, number of intubation attempts,need for optimisationmanoeuvres***,*** incidence of failed intubation***,*** rate of successfulintubation; *Changes in hemodynamicparameters* such as SBP, DBP, HR, SpO2 and *Complications*, if any.

**Placeof study:** The proposed study will be conducted in Department ofAnaesthesiology, Critical Care and Pain Medicine, University College of MedicalSciences & Guru Teg Bahadur Hospital, Delhi.

**Studyperiod:** The duration of the study will be from November 2018 toApril 2020.

**Studydesign:** After obtaining approval from the Institutional EthicsCommittee, this randomized single-blind trial will be undertaken after takingwritten informed consent from all the participating subjects.

**Samplesize:** Considering the variability of intubation time inface-to-face tracheal intubation of 2.46 seconds (interquartilerange=10.3-18.8) with a median of 14 seconds. Assuming the same variability inhead-end tracheal intubation, to estimate an absolute difference of 2 secondsin median intubation time at α=5% and power=80%, a sample of 25 patients isrequired in each group.

**Patientselection:** A total of 50 (25 in each group) adult patientsof either sex posted for elective surgical procedures requiring generalanaesthesia with tracheal intubation will be included in each group.

*Inclusioncriteria:* Patients between the age group 18-60 years, belonging toASA physical status I-II, Modified Mallampati Grade I and II, having mouthopening >3 finger breadths, thyromental distance >6 cms and BMI<30kg/m2  will be includedin this study.

*Exclusioncriteria:* Patients who do not give consent to participate in the study;patients with anticipated difficult airway or any airway tumor or prior neck orthyroid surgery; patients with history of recent upper respiratory tractinfection within past 15 days, cervical spine disorders, coagulation disorders orhaving features of raised intracranial pressure; or full stomach patients willbe excluded from this study.

 **Randomizationand group allocation:** Using a computer generated random numbertable, the patients will be randomly allocated to one of the two groups and trachealintubation with Airtraq video-laryngoscope will be done accordingly.

**Group F:**Face-to-face tracheal intubation by Airtraq video-laryngoscope

**GroupH:** Conventionalhead-end tracheal intubation by Airtraq video-laryngoscope

**Outcomemeasures:** Primary outcome measure is time taken for successfulintubation. The secondary outcome measures will include intubating conditionslike glottic view according to Percentage of Glottic Opening (POGO) score,Cormack and Lehane (C&L) score, ease of intubation, need for additionalmanoeuvres to facilitate intubation, attempts of intubation, incidence offailed intubation and hemodynamic response to laryngoscopy and intubation andcomplication if any.

**Statistical analysis:** Quantitativeparameters will be compared between the groups by Unpaired t-test/ Mann-WhitneyU test depending upon the nature of the data. Hemodynamic parameters will be comparedby repeated measure ANOVA followed by Dunnett’s test. Qualitative parameterswill be compared by Chi-square test/Fischer’s-Exact test. A p-value of <0.05will be considered as significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-18
• Study Completion: 2019-12-11
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

ASA physical status I-II Modified Mallampati Grade I and II Mouth opening >3 finger breadths Thyromental distance >6 cm BMI <30kg/m2.

Exclusion Criteria

• Patients who do not give consent to participate in the study.
• Anticipated difficult bag mask ventilation and difficult intubation.
• Any airway tumor or prior neck or thyroid surgery.
• History of recent upper respiratory tract infection within past 15 days, cervical spine disorders, coagulation disorders.
• Patients having features of raised intracranial pressure Full stomach patients.
• Patients with cardiovascular, cerebral, renal, hepatic, bronchospastic and endocrine disease or psychiatric disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intubation time	Once, time taken from the device entering the oral cavity until observation of the tracheal tube entering through the vocal cords on the video-monitor.

Secondary Outcome Measures

Name	Time	Method
Device Insertion time	once, time taken from the device entering the oral cavity until clear visualization of the glottis on the video-monitor.
Number of intubation attempts	once, at the end of intubation
Failed intubation	once, at the end of intubation
Glottic view	once, at the end of intubation
Hemodynamic parameters; heart rate, systolic and diastolic blood pressure, mean arterial pressure and SpO2	1 min, 3 min, 5 min, 10 min and 15 min after intubation

Trial Locations

Locations (1)

UCMS & GTB Hospital; 🇮🇳 East, DELHI, India

UCMS & GTB Hospital

🇮🇳East, DELHI, India

Dr Sujata Chaudhary

Principal investigator

9999051546

sujatac462@gmail.com