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

Not Applicable

Completed

• Conditions: Ventilation Therapy; Complications
• Interventions: Device: TTIP ventilation; Device: Mask Ventilation

• Registration Number: NCT05005390
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-26
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-13
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-17
• Results First Submitted: 2023-11-17
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Results First Posted: 2024-01-24
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mask ventilation, then TTIP ventilation	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.
Mask ventilation, then TTIP ventilation	Mask 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.
TTIP ventilation, then mask ventilation	TTIP 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.
TTIP ventilation, then mask ventilation	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Successful Ventilation	from start of ventilation to end of ventilation (about 1 minute)	Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.

Secondary Outcome Measures

Name	Time	Method
Peak Inspiratory Airway Pressure Achieved	from start of ventilation to end of ventilation (about 1 minute)	This is measured by readings from the ventilator used in the operating room
Dynamic Airway Resistance	from start of ventilation to end of ventilation (about 1 minute)	This is defined as the peak inspiratory flow divided by the corresponding airway pressure.
Expired Tidal Volume of Ventilation	from start of ventilation to end of ventilation (about 1 minute)	This is measured by readings from the ventilator used in the operating room
Satisfaction of the Providers Obtained With Post Ventilation Survey	end of surgery (about 1 hour after start)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States