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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2022-11-17

Brief Summary

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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

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Detailed Description

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Conditions

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Ventilation Therapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TTIP ventilation, then mask ventilation

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.

Group Type EXPERIMENTAL

TTIP ventilation

Intervention Type DEVICE

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 Ventilation

Intervention Type DEVICE

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

Mask ventilation, then TTIP ventilation

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.

Group Type ACTIVE_COMPARATOR

TTIP ventilation

Intervention Type DEVICE

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 Ventilation

Intervention Type DEVICE

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

Interventions

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TTIP ventilation

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.

Intervention Type DEVICE

Mask Ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No