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

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

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 Overview

• Status: Completed
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Device: TTIP ventilation; Device: Mask Ventilation

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Device: Mask Ventilation; In mask ventilation, a mask is placed over the nose and mouth.
Active Comparator: 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.	Device: 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.; Device: Mask Ventilation; In mask ventilation, a mask is placed over the nose and mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from start of ventilation to end of ventilation (about 1 minute)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expired Tidal Volume of Ventilation	This is measured by readings from the ventilator used in the operating room	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	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.	from start of ventilation to end of ventilation (about 1 minute)
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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Travis Markham, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Bag Mask Ventilation
• Other Study ID Numbers: HSC-MS-21-0478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes