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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Peak Inspiratory Airway Pressure Achieved |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Travis Markham, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2021 |
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| Mask Ventilation | Device | In mask ventilation, a mask is placed over the nose and mouth. |
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This is measured by readings from the ventilator used in the operating room
| from start of ventilation to end of ventilation (about 1 minute) |
| 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) |
| 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) |
| FG001 | 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. |
| Successfully Completed First Ventilation (Step 1) |
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| Successfully Completed Second Ventilation (Step 2) |
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| COMPLETED | Successfully Completed First and Second Ventilation |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| American Society of Anesthesiology (ASA) Classification | ASA Physical Status Classification System - The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA I :A normal healthy patient ASA II :A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
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| Mallampati Class | The Mallampati class identifies patients at risk for difficult intubation based on the structure of their oropharynx. Class I: soft palate, uvula, and pillars are visible Class II: soft palate and uvula are visible Class III: only the soft palate and base of the uvula are visible Class IV: only the hard palate is visible | Count of Participants | Participants |
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| Provider's training levels | Count of Participants | Participants |
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| Body Mass Index (BMI) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data were not collected for 11 participants in the TTIP Ventilation arm and the Mask ventilation arm. | Posted | Count of Participants | Participants | from start of ventilation to end of ventilation (about 1 minute) |
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| Secondary | Expired Tidal Volume of Ventilation | This is measured by readings from the ventilator used in the operating room | Posted | Mean | Standard Deviation | ml | from start of ventilation to end of ventilation (about 1 minute) |
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| Secondary | Peak Inspiratory Airway Pressure Achieved | This is measured by readings from the ventilator used in the operating room | Posted | Mean | Standard Deviation | cmH2O | from start of ventilation to end of ventilation (about 1 minute) |
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| Secondary | Dynamic Airway Resistance | This is defined as the peak inspiratory flow divided by the corresponding airway pressure. | Data were not collected for this outcome measure. | Posted | from start of ventilation to end of ventilation (about 1 minute) |
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| Secondary | Satisfaction of the Providers Obtained With Post Ventilation Survey | Data were not collected for this outcome measure. | Posted | Baseline before start of surgery |
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| Secondary | Satisfaction of the Providers Obtained With Post Ventilation Survey | Data were not collected for this outcome measure. | Posted | end of surgery (about 1 hour after start) |
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during time in PACU (about 30 minutes to 2 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | TTIP 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. | 0 | 147 | 0 | 147 | 0 | 147 |
| EG001 | Mask 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. | 0 | 147 | 0 | 147 | 0 | 147 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Travis Markham, MD | The University of Texas Health Science Center at Houston | 713-500-6200 | Travis.H.Markham@uth.tmc.edu |
| Nov 15, 2023 |
| Prot_SAP_000.pdf |
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