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N/A N=147 Randomized Triple-blind Treatment

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

Ventilation Therapy; Complications

Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Patients With Successful Ventilation — 127; 115 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
TTIP ventilation (Device); Mask Ventilation (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
Nov 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Successful Ventilation
127; 115
SECONDARY
Expired Tidal Volume of Ventilation
618.22; 719.48
SECONDARY
Peak Inspiratory Airway Pressure Achieved
19.82; 19.94
SECONDARY
Dynamic Airway Resistance
SECONDARY
Satisfaction of the Providers Obtained With Post Ventilation Survey
SECONDARY
Satisfaction of the Providers Obtained With Post Ventilation Survey

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

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05005390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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