Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy. The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.
Colonoscopy has become an essential part of the patient management, especially in the field of colorectal cancer prevention. About 15 million colonoscopies were done in the United States in 2012. Data from United States and European countries suggest that the majority of investigations are performed with the aid of sedation. Since sedation can cause significant respiratory depression, resulting in hypoxia, especially in obese and elder populations who are more likely to undergo colonoscopy, usually oxygen is provided to patients via a nasal cannula to minimize the risk of hypoxia. Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy. The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.
The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Time to First Intervention
The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.
Time frame: Usually 5 minutes
Number of Subjects Receiving Interventions for Airway Management
Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Duration of Intervention
Duration of intervention
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Oxygen Saturation Reading- Median
Oxygen saturation reading- Median
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Oxygen Saturation- Lowest Reading
Oxygen saturation- Lowest reading
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Number of Participants With Oxygen Saturation- Reading Below 90%
Number of participants with oxygen saturation- reading below 90%
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Tidal Volume (VT)
Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Respiratory Rate (RR)
Respiratory Rate (RR)
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
Minute Ventilation (MV)
Minute ventilation (MV)
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
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