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

Ventilation Therapy; Complications Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005390
• Other study ID #: HSC-MS-21-0478
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: November 17, 2022

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Satisfaction of the Providers Obtained With Post Ventilation Survey		Baseline before start of surgery
Secondary	Satisfaction of the Providers Obtained With Post Ventilation Survey		end of surgery (about 1 hour after start)