Trial Outcomes & Findings for Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway (NCT NCT05005390)

Last Updated: 2024-01-24

Results Overview

Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.

Recruitment status

COMPLETED

Study phase

Target enrollment

147 participants

Primary outcome timeframe

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

Results posted on

2024-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.
Overall Study STARTED	76	71
Overall Study Successfully Completed First Ventilation (Step 1)	64	52
Overall Study Successfully Completed Second Ventilation (Step 2)	63	63
Overall Study COMPLETED	57	50
Overall Study NOT COMPLETED	19	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TTIP Ventilation, Then Mask Ventilation n=76 Participants 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. 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.	Mask Ventilation, Then TTIP Ventilation n=71 Participants 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. 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.	Total n=147 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 14.8 • n=76 Participants	44.4 years STANDARD_DEVIATION 13.0 • n=71 Participants	46.2 years STANDARD_DEVIATION 14.0 • n=147 Participants
Sex: Female, Male Female	44 Participants n=76 Participants	37 Participants n=71 Participants	81 Participants n=147 Participants
Sex: Female, Male Male	32 Participants n=76 Participants	34 Participants n=71 Participants	66 Participants n=147 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	76 participants n=76 Participants	71 participants n=71 Participants	147 participants n=147 Participants
Body Mass Index (BMI)	36.1 kg/m^2 STANDARD_DEVIATION 7.3 • n=76 Participants	36.6 kg/m^2 STANDARD_DEVIATION 6.0 • n=71 Participants	36.3 kg/m^2 STANDARD_DEVIATION 6.7 • n=147 Participants
American Society of Anesthesiology (ASA) Classification ASA I :A normal healthy patient	2 Participants n=76 Participants	2 Participants n=71 Participants	4 Participants n=147 Participants
American Society of Anesthesiology (ASA) Classification ASA II :A patient with mild systemic disease	31 Participants n=76 Participants	35 Participants n=71 Participants	66 Participants n=147 Participants
American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease	43 Participants n=76 Participants	33 Participants n=71 Participants	76 Participants n=147 Participants
American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life	0 Participants n=76 Participants	1 Participants n=71 Participants	1 Participants n=147 Participants
American Society of Anesthesiology (ASA) Classification ASA V: A moribund patient who is not expected to survive without the operation	0 Participants n=76 Participants	0 Participants n=71 Participants	0 Participants n=147 Participants
American Society of Anesthesiology (ASA) Classification ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes	0 Participants n=76 Participants	0 Participants n=71 Participants	0 Participants n=147 Participants
Mallampati Class Class I: soft palate, uvula, and pillars are visible	24 Participants n=76 Participants	17 Participants n=71 Participants	41 Participants n=147 Participants
Mallampati Class Class II: soft palate and uvula are visible	26 Participants n=76 Participants	34 Participants n=71 Participants	60 Participants n=147 Participants
Mallampati Class Class III: only the soft palate and base of the uvula are visible	19 Participants n=76 Participants	16 Participants n=71 Participants	35 Participants n=147 Participants
Mallampati Class Class IV: only the hard palate is visible	7 Participants n=76 Participants	4 Participants n=71 Participants	11 Participants n=147 Participants
Provider's training levels Attending Anesthesiologists	9 Participants n=76 Participants	8 Participants n=71 Participants	17 Participants n=147 Participants
Provider's training levels Anesthesia assistants	19 Participants n=76 Participants	17 Participants n=71 Participants	36 Participants n=147 Participants
Provider's training levels Anesthesia residents	48 Participants n=76 Participants	46 Participants n=71 Participants	94 Participants n=147 Participants
Body Mass Index (BMI) < 30 kg/m^2	4 Participants n=76 Participants	3 Participants n=71 Participants	7 Participants n=147 Participants
Body Mass Index (BMI) greater than or equal to 30 kg/m^2 to less than 40 kg/m^2(Class 1&2 obesity)	55 Participants n=76 Participants	54 Participants n=71 Participants	109 Participants n=147 Participants
Body Mass Index (BMI) ≥ 40 kg/m^2 (Class 3 obesity)	17 Participants n=76 Participants	14 Participants n=71 Participants	31 Participants n=147 Participants

PRIMARY outcome

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

Population: Data were not collected for 11 participants in the TTIP Ventilation arm and the Mask ventilation arm.

Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.

Outcome measures

Outcome measures
Measure	TTIP Ventilation n=136 Participants 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 n=136 Participants In mask ventilation, a mask is placed over the nose and mouth.
Number of Patients With Successful Ventilation	127 Participants	115 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	TTIP Ventilation n=107 Participants 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 n=107 Participants In mask ventilation, a mask is placed over the nose and mouth.
Expired Tidal Volume of Ventilation	618.22 ml Standard Deviation 313.68	719.48 ml Standard Deviation 348.64

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	TTIP Ventilation n=107 Participants 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 n=107 Participants In mask ventilation, a mask is placed over the nose and mouth.
Peak Inspiratory Airway Pressure Achieved	19.82 cmH2O Standard Deviation 1.11	19.94 cmH2O Standard Deviation 1.76

SECONDARY outcome

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

Population: Data were not collected for this outcome measure.

This is defined as the peak inspiratory flow divided by the corresponding airway pressure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline before start of surgery

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: end of surgery (about 1 hour after start)

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

TTIP Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mask Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Travis Markham, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-6200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place