Clinical Trial: An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy

Brief Summary:

Purpose: To assess the utility of a new medical device that monitors a patient's breathing during medical procedures in which a patient is sedated, but not mechanically ventilated. In minor procedures, such as endoscopy (where the doctor examines a patient's digestive tract by a TV camera inserted through the mouth), patients do not require general anesthesia, in which a machine would take over their breathing while they are unconscious for surgery. However, during endoscopic procedures it is sometimes difficult for the anesthesiologist to monitor the patient's breathing—specifically, to monitor changes in breathing patterns and the adequacy of breathing. In endoscopy procedures, the room is darkened, and the patient's mouth is generally occupied by the endoscope. While the anesthesiologist can listen to the patient's breathing sounds with a stethoscope, this type of monitoring can only be done periodically, and there is limited ability to gauge the adequacy of ventilation. This study will use the ExSpiron Respiratory Volume Monitor (RVM), which measures non-invasive minute ventilation (MV), tidal volume (TV) and respiratory rate (RR), in patients undergoing an endoscopic procedure to provide additional information regarding the effects of clinical interventions such as drug administrations or airway maneuvers on the patient's respiratory status.

For patients who give informed consent, study participation means that they will have a PadSet consisting of 3 electrodes applied to the chest. Another component, a nasal cannula (a thin clear plastic tube that goes under the nose) will give patients supplemental oxygen, and is standard of care for endoscopy at UVM Medical Center. Patients will then be asked to breathe in and out of a portable spirometer (breath meter) for 30 seconds up to five times. This data will be compared to data recorded by the monitor to confirm tha

Detailed Summary:

The purpose of this study is to assess the utility of the ExSpiron Respiratory Variation Monitor in patients undergoing an interventional procedure with anesthesia. The primary outcome measure will be the average minute ventilation of the patient during the procedure. This study will also examine the correlation between clinical interventions such as drug administrations or airway maneuvers with data from the monitor. Additionally the study may provide information about the ability of this new monitoring system to prevent hypoxemia during these procedures and to consider its utility, compared with capnography, to detect hypopnea.

Background Assessing the adequacy of ventilation during Monitored Anesthesia Care (MAC) and sedation is difficult. Agents used to provide procedural sedation can depress ventilatory drive and can interfere with airway patency, making it much more likely that the patient will hypoventilate and experience partial or complete obstruction to ventilation. [It is actually clinically easier to administer general anesthesia and insert an airway management device such as an endotracheal tube or a laryngeal mask airway , however given the superior recovery profile following sedation vs. general anesthesia, it is usually preferable to administer sedation, if the procedure can be performed with its use.] The American Society of Anesthesiologists maintains a database of closed malpractice claims which allows analysis of patterns of injury. A study considering claims from MAC/sedation cases found that 40% of the MAC claims resulted in death or brain damage, that 25% of the claims that were associated with oversedation/hypoventilation occurred in the endoscopy suite, and that 44% of the oversedation cases could have been prevented by better monitoring.1 A study comparing claims from remote locations (such as endoscopy) with operating rooms, found that 50% of re
Sponsor: Donald Mathews

Current Primary Outcome: Average minute ventilation in patients cared for using the ExSpiron Respiratory Variation Monitor (RVM) compared to patients with routine monitoring in patients undergoing upper gastrointestinal endoscopy [ Time Frame: Duration of procedure: Approximately 60 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of airway maneuvers required to maintain ventilation in each group [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  • Effectiveness of airway maneuvers in each group (change in minute ventilation) [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  • Time required to return to baseline ventilator parameters following the procedure. [ Time Frame: Duration of procedure and time in the recovery room: Approximately 120 minutes ]
  • Incidence of hypopnea in each group [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  • Average oxygen saturation between the two groups [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  • Percentage of time with oxygenation less than 90% between the two groups [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  • The ability of respiratory parameters with capnography to assess states of hypoventilation between the two groups [ Time Frame: Duration of procedure: Approximately 60 minutes ]


Original Secondary Outcome: Same as current

Information By: University of Vermont

Dates:
Date Received: September 18, 2014
Date Started: September 2014
Date Completion: December 2016
Last Updated: March 8, 2016
Last Verified: March 2016