Brief Summary
Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. This study will examine whether Optiflow can do this, and compare the pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.
Brief Title
Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask
Detailed Description
The use of high flow nasal cannula (HFNC) originated in neonatal care, and has become widespread in its application for patients that are high risk for hypoxemia, both in critical care and emergency settings. Therefore, high flow nasal oxygenation continues to be studied in airway management for preoxygenation, as well as maintenance of oxygenation in airway procedures. Optiflow™, a humidified high flow nasal cannula, has already been shown to be useful in preventing desaturation during intubation in ICU patients versus the non-rebreathing mask, in addition to, prolonging safe apnea time in patients with potential difficult airways. Additionally, preoxygenation with HFNC prior to intubation of patients in hypoxemic respiratory failure has also been shown to decrease desaturation during apnea compared to preoxygenation with traditional bag valve mask. The morbidly obese patient presents a separate group of challenges to the anesthesiologist in regards to mask ventilation and intubation. Obesity (along with other factors) has been shown to contribute to difficulty with mask ventilation. Obese patients have altered respiratory physiology, including decreased functional residual capacity, increased oxygen consumption and lower tidal volumes, as compared to the non-obese patient. These factors contribute to obese patients potentially having a shorter apnea time before desaturating during induction of general anesthesia, as compared to the non-obese patient. Weight is inversely correlated with safe apnea time. Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. If demonstrated to be efficacious as a method for preoxygenation and prolongation of apneic time, this could provide a safer environment for intubation in this particular patient population.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Obesity, Morbid
Eligibility Criteria
Inclusion Criteria:
* Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
* BMI \> 40 kg/m2
* American Society of Anesthesiology (ASA) Physical Status II-III
Exclusion Criteria:
* Chronic hypoxemia (SpO2 \<94% on room air or on home oxygen)
* Acute respiratory failure
* Coronary artery disease and/or congestive heart failure
* Moderate-Severe pulmonary hypertension and/or RV dysfunction
* Full stomach (recently eaten)
* Pregnancy
* Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)
* Respiratory tract pathology
* Facial Abnormality
* American Society of Anesthesiology (ASA) Physical Status IV-V
* Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
* BMI \> 40 kg/m2
* American Society of Anesthesiology (ASA) Physical Status II-III
Exclusion Criteria:
* Chronic hypoxemia (SpO2 \<94% on room air or on home oxygen)
* Acute respiratory failure
* Coronary artery disease and/or congestive heart failure
* Moderate-Severe pulmonary hypertension and/or RV dysfunction
* Full stomach (recently eaten)
* Pregnancy
* Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)
* Respiratory tract pathology
* Facial Abnormality
* American Society of Anesthesiology (ASA) Physical Status IV-V
Inclusion Criteria
Inclusion Criteria:
* Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
* BMI \> 40 kg/m2
* American Society of Anesthesiology (ASA) Physical Status II-III
* Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
* BMI \> 40 kg/m2
* American Society of Anesthesiology (ASA) Physical Status II-III
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03009877
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-7360
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Preoxygenation With Optiflow™, a High Flow Nasal Cannula (HFNC), is Superior to Preoxygenation With Facemask in Morbidly Obese Patients Undergoing General Anesthesia
Primary Outcomes
Outcome Description
Intraoperatively, apneic time will be record from the time of administration of the muscle relaxant. The time until the first desaturation will be recorded. The maximum time of measurement will be 10 minutes.
Outcome Measure
Time to desaturation
Outcome Time Frame
up to 10 minutes
Secondary Outcomes
Outcome Description
The time until hypercarbia to more than 65 mmHg will be measured from the time of administration of the muscle relaxant. The time until transcutaneous CO2 is \> 65 mmHg will be recorded, unless 10 minutes is reached before that level is reached.
Outcome Time Frame
up to 10 minutes
Outcome Measure
Time until hypercarbia > 65 mmHg
Outcome Description
Assessment of accurate correlation between transcutaneous CO2 monitoring, end tidal CO2, and/or PaCO2 will be performed up to 10 minutes.
Outcome Time Frame
up to 10 minutes
Outcome Measure
Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tracey Straker
Investigator Email
tstraker@montefiore.org
Investigator Phone