Health Condition 1: 8- Other Procedures
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female adults in the age group between 18 to 60 years (both inclusive) 2.Patients with a body mass index (BMI), between 18.5 to 35.0 kg/m2 3.Patients with physical status class I or class II or class III as assessed by American society of Anaesthesiologist (ASA) at the discretion of principal investigator (PI) 4.Patients who require oral endo-tracheal intubation under general anaesthesia 5.Patients who agree to sign the written informed consent and comply with the protocol requirements Additional inclusion criteria for cohort 1 (normal airway): 6.Patients with normal airway defined as: •Modified Mallampati class I and II •Thyromental distance (TMD) > 6.5 cm. Additional inclusion criteria for cohort 2 (anticipated difficult airway): 7.Patients with anticipated difficult airway defined as: •Modified Mallampati class III and IV •Thyromental distance (TMD) = 6.5 cm
Exclusion criteria
Exclusion criteria: 1.Intensive care unit (ICU) patients 2.Patients with reactive airway disease or epilepsy 3.Patients with active oral lesions 4.Patients requiring awake intubation 5.Patients with active cough 6.Patients with known allergy to anaesthesia induction drugs as determined by PI 7.Patients requiring rapid sequence intubation and at risk of gastric aspiration 8.Patients with known cervical spine pathology 9.Patients with history of myocardial infarction (MI) less than three months prior to screening 10.Female patients who are pregnant or currently lactating 11.Patients with history of psychiatric or neurological disease conditions 12.Patients with untreatable or terminal stage illness 13.Patients who have any condition that in the judgement of investigator make the patient inappropriate for entry into this clinical trial 14.Patients who are not willing to sign written informed consent and follow the procedures. 15.Patients with cervical instability 16.Patient with poor dentition with high risk of damage at the discretion of PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1 & Cohort 2 1.Larynogoscopic view 2.Time to intubate (TTI) 3.Intubation status 4.Ease of intubationTimepoint: 1.Day-1 2.Day-1 3.Day-1 4.Day-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Hemodynamic responses to intubation 2.Incidence of adverse device effect 3.Incidence of any device deficiency Timepoint: 1.Day-1 2.Day-1 3.Day-1 | — |
Countries
India
Contacts
Vphore Labs Pvt Ltd