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OpenTrials
Completed

NCT Number: NCT05005390

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

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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Key information

Conditions

Ventilation Therapy; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Number of Patients With Successful Ventilation

    Time frame: 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 outcomes

  1. Expired Tidal Volume of Ventilation

    Time frame: from start of ventilation to end of ventilation (about 1 minute)

    This is measured by readings from the ventilator used in the operating room

  2. Peak Inspiratory Airway Pressure Achieved

    Time frame: from start of ventilation to end of ventilation (about 1 minute)

    This is measured by readings from the ventilator used in the operating room

  3. Dynamic Airway Resistance

    Time frame: 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.

  4. Satisfaction of the Providers Obtained With Post Ventilation Survey

    Time frame: Baseline before start of surgery

  5. Satisfaction of the Providers Obtained With Post Ventilation Survey

    Time frame: end of surgery (about 1 hour after start)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2021
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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