Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A (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. |
Device: TTIP ventilation then mask 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.
|
| Active Comparator: Group B (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. |
Device: Mask Ventilation then TTIP ventilation
In mask ventilation, a mask is placed over the nose and mouth.
|
Outcome Measures
Primary Outcome Measures
- Number of patients with successful ventilation [Baseline before start of surgery]
successful ventilation is defined when atleast one of the first three breaths shows three phases of expired Carbon dioxide(CO2) profile.
- Number of patients with successful ventilation [end of surgery (about 1 hour after start)]
successful ventilation is defined when atleast one of the first three breaths shows three phases of expired CO2 profile.
Secondary Outcome Measures
- Change in Expired tidal volume of ventilation [Baseline before start of surgery,end of surgery (about 1 hour after start)]
This is measured by readings from the ventilator used in the operating room
- Peak inspiratory airway pressure achieved [Baseline before start of surgery]
This is measured by readings from the ventilator used in the operating room
- Peak inspiratory airway pressure achieved [end of surgery (about 1 hour after start)]
This is measured by readings from the ventilator used in the operating room
- Dynamic airway resistance [Baseline before start of surgery]
This is defined as the peak inspiratory flow divided by the corresponding airway pressure.
- Dynamic airway resistance [end of surgery (about 1 hour after start)]
This is defined as the peak inspiratory flow divided by the corresponding airway pressure.
- 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)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Travis Markham, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-21-0478