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

The University of Texas System (UT)

Status: Completed

Conditions: Ventilation Therapy; Complications

Treatments: Device: Mask Ventilation; Device: TTIP ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05005390

HSC-MS-21-0478

Details and patient eligibility

About

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

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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147 participants in 2 patient groups

TTIP ventilation, then mask ventilation

Experimental group

Description:

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.

Treatment:

Device: TTIP ventilation

Device: Mask Ventilation

Mask ventilation, then TTIP ventilation

Active Comparator group

Description:

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.

Treatment:

Device: TTIP ventilation

Device: Mask Ventilation