Colonoscopy, Oxygenation, Ventilation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOxygen via nasal cannula
Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.
DEVICEOxygen via SuperNO2VA nasal mask
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.
Sponsors
Revolutionary Medical Devices, Inc.
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years or older * BMI of 30-50 * ASA 1-3 Scheduled for colonoscopy with sedation
Exclusion criteria
* Untreated ischemic heart disease * Acute and chronic respiratory disorders, including COPD and asthma * Emergent procedures * Planned use of an invasive airway (ie: supra-glottic device, LMA, etc) * Pregnant women * Nasal or oral disease resulting in difficulty of either nasal breathing or mouth breathing * Patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Intervention | Usually 5 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Intervention | Duration of colonoscopy procedure (usually 30 minutes) | Duration of intervention |
| Oxygen Saturation Reading- Median | Duration of colonoscopy procedure (usually 30 minutes) | Oxygen saturation reading- Median |
| Oxygen Saturation- Lowest Reading | Duration of colonoscopy procedure (usually 30 minutes) | Oxygen saturation- Lowest reading |
| Number of Subjects Receiving Interventions for Airway Management | Duration of colonoscopy procedure (usually 30 minutes) | 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 |
| Tidal Volume (VT) | Duration of colonoscopy procedure (usually 30 minutes) | Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation. |
| Respiratory Rate (RR) | Duration of colonoscopy procedure (usually 30 minutes) | Respiratory Rate (RR) |
| Minute Ventilation (MV) | Duration of colonoscopy procedure (usually 30 minutes) | Minute ventilation (MV) |
| Number of Participants With Oxygen Saturation- Reading Below 90% | Duration of colonoscopy procedure (usually 30 minutes) | Number of participants with oxygen saturation- reading below 90% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.
Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center. | 73 |
| Oxygen Via SuperNO2VA Nasal Mask 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.
Oxygen via SuperNO2VA nasal mask: 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. | 63 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 6 | 7 |
| Overall Study | Location of procedure changed | 2 | 8 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Screen fail | 1 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Oxygen Via SuperNO2VA Nasal Mask | Total | Oxygen Via Nasal Cannula (Standard of Care) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 25 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 111 Participants | 61 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 63 Participants | 136 Participants | 73 Participants |
| Sex: Female, Male Female | 33 Participants | 80 Participants | 47 Participants |
| Sex: Female, Male Male | 30 Participants | 56 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 70 |
| other Total, other adverse events | 0 / 79 | 0 / 70 |
| serious Total, serious adverse events | 0 / 79 | 0 / 70 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Time to First Intervention | 10 minutes | Standard Deviation 12 |
| Oxygen Via SuperNO2VA Nasal Mask | Time to First Intervention | 19 minutes | Standard Deviation 10 |
Secondary
Duration of Intervention
Duration of intervention
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Duration of Intervention | 19 minutes | Standard Deviation 28 |
| Oxygen Via SuperNO2VA Nasal Mask | Duration of Intervention | 12 minutes | Standard Deviation 31 |
Secondary
Minute Ventilation (MV)
Minute ventilation (MV)
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Minute Ventilation (MV) | 2 minutes after induction | 8.41 Liters per minute | Standard Deviation 6.44 |
| Oxygen Via Nasal Cannula (Standard of Care) | Minute Ventilation (MV) | Baseline | 14.29 Liters per minute | Standard Deviation 8.01 |
| Oxygen Via Nasal Cannula (Standard of Care) | Minute Ventilation (MV) | 4 minutes after induction | 8.82 Liters per minute | Standard Deviation 6.86 |
| Oxygen Via Nasal Cannula (Standard of Care) | Minute Ventilation (MV) | 6 minutes after induction | 9.36 Liters per minute | Standard Deviation 5.99 |
| Oxygen Via Nasal Cannula (Standard of Care) | Minute Ventilation (MV) | 5 minutes before end of procedure | 10.29 Liters per minute | Standard Deviation 8.27 |
| Oxygen Via Nasal Cannula (Standard of Care) | Minute Ventilation (MV) | end of procedure | 12.21 Liters per minute | Standard Deviation 9.19 |
| Oxygen Via SuperNO2VA Nasal Mask | Minute Ventilation (MV) | 5 minutes before end of procedure | 12.18 Liters per minute | Standard Deviation 10.82 |
| Oxygen Via SuperNO2VA Nasal Mask | Minute Ventilation (MV) | 6 minutes after induction | 9.94 Liters per minute | Standard Deviation 8.06 |
| Oxygen Via SuperNO2VA Nasal Mask | Minute Ventilation (MV) | Baseline | 14.52 Liters per minute | Standard Deviation 6.31 |
| Oxygen Via SuperNO2VA Nasal Mask | Minute Ventilation (MV) | 2 minutes after induction | 9.16 Liters per minute | Standard Deviation 5.96 |
| Oxygen Via SuperNO2VA Nasal Mask | Minute Ventilation (MV) | end of procedure | 13.48 Liters per minute | Standard Deviation 9.01 |
| Oxygen Via SuperNO2VA Nasal Mask | Minute Ventilation (MV) | 4 minutes after induction | 9.62 Liters per minute | Standard Deviation 6.76 |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Number of Participants With Oxygen Saturation- Reading Below 90% | 16 Participants |
| Oxygen Via SuperNO2VA Nasal Mask | Number of Participants With Oxygen Saturation- Reading Below 90% | 3 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Number of Subjects Receiving Interventions for Airway Management | 46 Participants |
| Oxygen Via SuperNO2VA Nasal Mask | Number of Subjects Receiving Interventions for Airway Management | 14 Participants |
Secondary
Oxygen Saturation- Lowest Reading
Oxygen saturation- Lowest reading
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation- Lowest Reading | 2 minutes after induction | 96.22 percentage of oxygen saturation | Standard Deviation 6.12 |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation- Lowest Reading | 6 minutes after induction | 98.17 percentage of oxygen saturation | Standard Deviation 3.32 |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation- Lowest Reading | Baseline | 99.11 percentage of oxygen saturation | Standard Deviation 1.76 |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation- Lowest Reading | 5 minutes before end of procedure | 97.76 percentage of oxygen saturation | Standard Deviation 2.66 |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation- Lowest Reading | 4 minutes after induction | 97.57 percentage of oxygen saturation | Standard Deviation 4.79 |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation- Lowest Reading | end of procedure | 97.94 percentage of oxygen saturation | Standard Deviation 2.11 |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation- Lowest Reading | end of procedure | 99.19 percentage of oxygen saturation | Standard Deviation 1.11 |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation- Lowest Reading | Baseline | 99.23 percentage of oxygen saturation | Standard Deviation 1.53 |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation- Lowest Reading | 2 minutes after induction | 99.31 percentage of oxygen saturation | Standard Deviation 1.47 |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation- Lowest Reading | 4 minutes after induction | 99.39 percentage of oxygen saturation | Standard Deviation 1.21 |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation- Lowest Reading | 6 minutes after induction | 99.52 percentage of oxygen saturation | Standard Deviation 0.82 |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation- Lowest Reading | 5 minutes before end of procedure | 99.33 percentage of oxygen saturation | Standard Deviation 1.03 |
Secondary
Oxygen Saturation Reading- Median
Oxygen saturation reading- Median
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation Reading- Median | Baseline | 100.0 percentage of oxygen saturation |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation Reading- Median | 2 minutes after induction | 98 percentage of oxygen saturation |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation Reading- Median | 4 minutes after induction | 99 percentage of oxygen saturation |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation Reading- Median | 6 minutes after induction | 99 percentage of oxygen saturation |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation Reading- Median | 5 minutes before end of procedure | 99 percentage of oxygen saturation |
| Oxygen Via Nasal Cannula (Standard of Care) | Oxygen Saturation Reading- Median | end of procedure | 98 percentage of oxygen saturation |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation Reading- Median | 5 minutes before end of procedure | 100 percentage of oxygen saturation |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation Reading- Median | Baseline | 100 percentage of oxygen saturation |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation Reading- Median | 6 minutes after induction | 100 percentage of oxygen saturation |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation Reading- Median | 2 minutes after induction | 100 percentage of oxygen saturation |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation Reading- Median | end of procedure | 100 percentage of oxygen saturation |
| Oxygen Via SuperNO2VA Nasal Mask | Oxygen Saturation Reading- Median | 4 minutes after induction | 100 percentage of oxygen saturation |
Secondary
Respiratory Rate (RR)
Respiratory Rate (RR)
Time frame: Duration of colonoscopy procedure (usually 30 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Respiratory Rate (RR) | Baseline | 15.07 respiration per minute | Standard Deviation 4.57 |
| Oxygen Via Nasal Cannula (Standard of Care) | Respiratory Rate (RR) | 2 minutes after induction | 15.15 respiration per minute | Standard Deviation 5.32 |
| Oxygen Via Nasal Cannula (Standard of Care) | Respiratory Rate (RR) | 4 minutes after induction | 17.77 respiration per minute | Standard Deviation 5.36 |
| Oxygen Via Nasal Cannula (Standard of Care) | Respiratory Rate (RR) | 6 minutes after induction | 18.70 respiration per minute | Standard Deviation 4.87 |
| Oxygen Via Nasal Cannula (Standard of Care) | Respiratory Rate (RR) | 5 minutes before end of procedure | 18.39 respiration per minute | Standard Deviation 5.17 |
| Oxygen Via Nasal Cannula (Standard of Care) | Respiratory Rate (RR) | end of procedure | 17.69 respiration per minute | Standard Deviation 4.5 |
| Oxygen Via SuperNO2VA Nasal Mask | Respiratory Rate (RR) | 5 minutes before end of procedure | 17.02 respiration per minute | Standard Deviation 4.4 |
| Oxygen Via SuperNO2VA Nasal Mask | Respiratory Rate (RR) | Baseline | 15.36 respiration per minute | Standard Deviation 4.15 |
| Oxygen Via SuperNO2VA Nasal Mask | Respiratory Rate (RR) | 6 minutes after induction | 17.48 respiration per minute | Standard Deviation 4.77 |
| Oxygen Via SuperNO2VA Nasal Mask | Respiratory Rate (RR) | 2 minutes after induction | 15.21 respiration per minute | Standard Deviation 4.39 |
| Oxygen Via SuperNO2VA Nasal Mask | Respiratory Rate (RR) | end of procedure | 17.50 respiration per minute | Standard Deviation 5.63 |
| Oxygen Via SuperNO2VA Nasal Mask | Respiratory Rate (RR) | 4 minutes after induction | 16.95 respiration per minute | Standard Deviation 4.57 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxygen Via Nasal Cannula (Standard of Care) | Tidal Volume (VT) | Baseline | 1032.80 milliliters | Standard Deviation 583.74 |
| Oxygen Via Nasal Cannula (Standard of Care) | Tidal Volume (VT) | 2 minutes after induction | 527.01 milliliters | Standard Deviation 367.54 |
| Oxygen Via Nasal Cannula (Standard of Care) | Tidal Volume (VT) | 4 minutes after induction | 533.26 milliliters | Standard Deviation 467.47 |
| Oxygen Via Nasal Cannula (Standard of Care) | Tidal Volume (VT) | 6 minutes after induction | 540.16 milliliters | Standard Deviation 417.28 |
| Oxygen Via Nasal Cannula (Standard of Care) | Tidal Volume (VT) | 5 minutes before end of procedure | 610.38 milliliters | Standard Deviation 584.06 |
| Oxygen Via Nasal Cannula (Standard of Care) | Tidal Volume (VT) | end of procedure | 724.72 milliliters | Standard Deviation 538.9 |
| Oxygen Via SuperNO2VA Nasal Mask | Tidal Volume (VT) | 5 minutes before end of procedure | 735.76 milliliters | Standard Deviation 614.42 |
| Oxygen Via SuperNO2VA Nasal Mask | Tidal Volume (VT) | Baseline | 1011.39 milliliters | Standard Deviation 462.3 |
| Oxygen Via SuperNO2VA Nasal Mask | Tidal Volume (VT) | 6 minutes after induction | 613.15 milliliters | Standard Deviation 510.71 |
| Oxygen Via SuperNO2VA Nasal Mask | Tidal Volume (VT) | 2 minutes after induction | 625.31 milliliters | Standard Deviation 380.17 |
| Oxygen Via SuperNO2VA Nasal Mask | Tidal Volume (VT) | end of procedure | 879.52 milliliters | Standard Deviation 650.92 |
| Oxygen Via SuperNO2VA Nasal Mask | Tidal Volume (VT) | 4 minutes after induction | 589.22 milliliters | Standard Deviation 380.58 |