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OpenTrials
Completed

NCT Number: NCT03139448

Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen via nasal cannula

Device

Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.

Oxygen via SuperNO2VA nasal mask

Device

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.

Primary outcomes

  1. Time to First Intervention

    Time frame: 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 outcomes

  1. Number of Subjects Receiving Interventions for Airway Management

    Time frame: 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

  2. Duration of Intervention

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Duration of intervention

  3. Oxygen Saturation Reading- Median

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Oxygen saturation reading- Median

  4. Oxygen Saturation- Lowest Reading

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Oxygen saturation- Lowest reading

  5. Number of Participants With Oxygen Saturation- Reading Below 90%

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Number of participants with oxygen saturation- reading below 90%

  6. Tidal Volume (VT)

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.

  7. Respiratory Rate (RR)

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Respiratory Rate (RR)

  8. Minute Ventilation (MV)

    Time frame: Duration of colonoscopy procedure (usually 30 minutes)

    Minute ventilation (MV)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Revolutionary Medical Devices, Inc.

Registry information

Official study title

Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy: a Prospective Randomized Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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