Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation

Official Title
-----------------
Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway:A Prospective Randomized and Blinded Trial.

Conditions
-----------------
Ventilation Therapy; Complications

Intervention / Treatment
-----------------
* Device: TTIP ventilation then mask ventilation
* Device: Mask Ventilation then TTIP ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30 kg/m2 Mallampati class III or IV Requiring general anesthesia Exclusion Criteria: Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma American Society of Anesthesiologists (ASA)physical status classification ≥IV Emergency surgery Induction requiring rapid sequence for intubation Patients requiring awake intubation Pregnant women Untreated ischemic heart disease Contraindication for mask ventilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (TTIP ventilation then mask ventilation )<br>Subjects will first be ventilated with the TTIP technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1).Subjects will then be ventilated with mask ventilation (Step 2).In Step 1, if ventilation fails with the TTIP technique for all of the first three consecutive breaths, the subject will be crossed over to the mask ventilation. If ventilation fails again with all the first three consecutive breaths after crossover,the study will be terminated.The routine care is resumed including tracheal intubation or laryngeal mask airway (LMA) insertion. | Device: TTIP ventilation then mask ventilation<br>* In TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.<br>|
| Active Comparator: Group B (mask ventilation, then TTIP ventilation)<br>Subjects will first be ventilated with the mask technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1).Subjects will then be ventilated with TTIP technique (Step 2).In Step 1, if ventilation fails for all of the first three consecutive breaths, the subject will be crossed over to the TTIP ventilation. If ventilation fails again with all the first three consecutive breaths after crossover,the study will be terminated.The routine care is resumed including tracheal intubation or LMA insertion. | Device: Mask Ventilation then TTIP ventilation<br>* In mask ventilation, a mask is placed over the nose and mouth.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful ventilation | successful ventilation is defined when atleast one of the first three breaths shows three phases of expired Carbon dioxide(CO2) profile. | Baseline before start of surgery | 
| Number of patients with successful ventilation | successful ventilation is defined when atleast one of the first three breaths shows three phases of expired CO2 profile. | end of surgery (about 1 hour after start) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Expired tidal volume of ventilation | This is measured by readings from the ventilator used in the operating room | Baseline before start of surgery,end of surgery (about 1 hour after start) | 
| Peak inspiratory airway pressure achieved | This is measured by readings from the ventilator used in the operating room | Baseline before start of surgery | 
| Peak inspiratory airway pressure achieved | This is measured by readings from the ventilator used in the operating room | end of surgery (about 1 hour after start) | 
| Dynamic airway resistance | This is defined as the peak inspiratory flow divided by the corresponding airway pressure. | Baseline before start of surgery | 
| Dynamic airway resistance | This is defined as the peak inspiratory flow divided by the corresponding airway pressure. | end of surgery (about 1 hour after start) | 
| Satisfaction of the providers obtained with post ventilation survey |  | Baseline before start of surgery | 
| Satisfaction of the providers obtained with post ventilation survey |  | end of surgery (about 1 hour after start) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bag Mask Ventilation