Morbid Obesity, Noninvasive Ventilation, Deep Sedation
Conditions
Brief summary
This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.
Detailed description
The respiratory physiology of morbidly obese patients is altered due to restriction of the chest wall motion which decreases pulmonary compliance. In addition, anatomical changes lead to an increased incidence of airway obstruction in morbidly obese patients during periods of sedation. Both a typical nasal cannula and high flow nasal cannula provide supplemental oxygen to the patients to prevent desaturation and hypoxia. However, the higher flow rates of high flow nasal cannulas are able to produce allows for washout of carbon dioxide from the respiratory system aiding with ventilation and creates 3 to 5 cm H2O of positive end expiration pressure which helps prevent collapse of the airway aiding with oxygenation.
Interventions
DEVICEHigh flow nasal cannula
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
DEVICENasal Cannula
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index greater than or equal to 40 * Scheduled for a gastrointestinal endoscopy that requires MAC sedation
Exclusion criteria
* Body Mass Index less than 40 * Pregnant * Require either invasive or non-invasive ventilation for respiratory failure * Use home oxygen * Ventilation is via a tracheostomy * The procedure is emergent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Maintain Oxygenation | During the period of sedation, on average up to 1 hour | The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Airway Adjuncts During Procedure | During the period of sedation, on average up to 1 hour | The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure. |
| Number of Participants Who Need an Increase in Fraction of Inspired Oxygen | During period of sedation, on average up to 1 hour | Need to increase the FiO2 to maintain adequate oxygenation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Flow Nasal Cannula High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation. | 22 |
| Nasal Cannula Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula: High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation. | 19 |
| Total | 41 |
Baseline characteristics
| Characteristic | High Flow Nasal Cannula | Nasal Cannula | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 19 Participants | 41 Participants |
| Age, Continuous | 47.7 years STANDARD_DEVIATION 12.5 | 43.4 years STANDARD_DEVIATION 12.2 | 46 years STANDARD_DEVIATION 12.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 15 Participants | 34 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 19 |
| other Total, other adverse events | 0 / 22 | 0 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 19 |
Outcome results
Primary
Ability to Maintain Oxygenation
The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.
Time frame: During the period of sedation, on average up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Flow Nasal Canula | Ability to Maintain Oxygenation | 0.55 manipulations | Standard Deviation 0.55 |
| Nasal Canula | Ability to Maintain Oxygenation | 0.61 manipulations | Standard Deviation 1.03 |
Secondary
Number of Participants Requiring Airway Adjuncts During Procedure
The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.
Time frame: During the period of sedation, on average up to 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Nasal Canula | Number of Participants Requiring Airway Adjuncts During Procedure | 0 Participants |
| Nasal Canula | Number of Participants Requiring Airway Adjuncts During Procedure | 0 Participants |
Secondary
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen
Need to increase the FiO2 to maintain adequate oxygenation
Time frame: During period of sedation, on average up to 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Nasal Canula | Number of Participants Who Need an Increase in Fraction of Inspired Oxygen | 6 Participants |
| Nasal Canula | Number of Participants Who Need an Increase in Fraction of Inspired Oxygen | 3 Participants |