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

The University of Texas Health Science Center, Houston147 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

147

Conditions

Ventilation Therapy; Complications

Interventions

TTIP ventilationDEVICE

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.

Mask VentilationDEVICE

In mask ventilation, a mask is placed over the nose and mouth.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Patients With Successful Ventilation

Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.

Time frame: from start of ventilation to end of ventilation (about 1 minute)

Secondary Outcomes

Expired Tidal Volume of Ventilation

This is measured by readings from the ventilator used in the operating room

Time frame: from start of ventilation to end of ventilation (about 1 minute)

Peak Inspiratory Airway Pressure Achieved

This is measured by readings from the ventilator used in the operating room

Time frame: from start of ventilation to end of ventilation (about 1 minute)

Dynamic Airway Resistance

This is defined as the peak inspiratory flow divided by the corresponding airway pressure.

Time frame: from start of ventilation to end of ventilation (about 1 minute)

Satisfaction of the Providers Obtained With Post Ventilation Survey

Time frame: Baseline before start of surgery

Satisfaction of the Providers Obtained With Post Ventilation Survey

Time frame: end of surgery (about 1 hour after start)

Data from ClinicalTrials.gov

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