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

NCT05005390 | Completed Results FDA Device

• 1 other identifier: HSC-MS-21-0478
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Conditions

Ventilation Therapy; Complications

Keywords

Bag Mask Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Expired Tidal Volume of Ventilation

  from start of ventilation to end of ventilation (about 1 minute)

• Peak Inspiratory Airway Pressure Achieved

  from start of ventilation to end of ventilation (about 1 minute)

• Dynamic Airway Resistance

  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)

Study Arms (2)

TTIP ventilation, then mask ventilation

EXPERIMENTAL

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; Device: Mask Ventilation

Mask ventilation, then TTIP ventilation

ACTIVE COMPARATOR

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; Device: Mask Ventilation

Interventions

TTIP ventilation 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, then TTIP ventilation; TTIP ventilation, then mask ventilation

Mask Ventilation DEVICE

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

Mask ventilation, then TTIP ventilation; TTIP ventilation, then mask ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>30 kg/m2
• Mallampati class III or IV
• Requiring general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Limitations and Caveats

We calculated the sample size based on a parallel study design that resulted in a sample size of 245. We later performed a sample size calculation based on a crossover study design and realized that by enrolling one hundred forty-seven patients, we would achieve greater than 80% power for our primary analysis to detect a significant difference between the techniques with type I error (α) \< 0.05, even with a possible 10% dropout. Therefore, we terminated our study with 147 patients.

Results Point of Contact

• Title: Travis Markham, MD
• Organization: The University of Texas Health Science Center at Houston

Travis.H.Markham@uth.tmc.edu

713-500-6200

Study Officials

• Travis Markham, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: July 26, 2021
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)