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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310230
Recruitment Status : Unknown
Verified March 2016 by Donald Mathews, University of Vermont.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
Respiratory Motion, Inc.
Information provided by (Responsible Party):
Donald Mathews, University of Vermont

Tracking Information
First Submitted Date  ICMJE September 18, 2014
First Posted Date  ICMJE December 8, 2014
Last Update Posted Date March 10, 2016
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy
Official Title  ICMJE 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 that the monitor is recording accurately. The procedure will then go forward in the normal fashion. Patients will be randomly placed into one of two groups. In the first group during the procedure, the anesthesiologist will not be able to see the numbers (MV, TV, and RR) displayed screen of the monitor, so the data will not be used to guide the patient's clinical care. In the second group, the anesthesiologist will be able to see the RVM measurements of MV, TV, and RR to evaluate the effect of the interventions. Monitoring for both groups will continue in the recovery room, until discharge.

Detailed Description

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 remote location claims involving monitored anesthesia care, the proportion of claims for death was increased in remote location claims [54 vs. 29% (operating room claims)], respiratory damaging events were more common in remote location claims (44 vs. 20%), with inadequate oxygenation/ventilation the most common specific event (21 vs. 3% in operating room claims), and that remote location claims were more often judged as being preventable by better monitoring (32 vs. 8% for operating room claims).2

Upper endoscopy procedures, such as upper GI endoscopy and endoscopic retrograde cholangiopancreatography (ERCP), are particularly challenging where the anesthesiologist has limited access to the patient's head and is working in darkened rooms. Indeed investigators have found it very difficult to find a combination of propofol and short acting opioid that allows instrumentation of the esophagus without "intolerable ventilatory depression".3 Trying to assess ventilation by observing chest excursion or listening to ventilation with a stethoscope under these conditions can be difficult and can be done only periodically. Side-stream nasal cannula end-tidal capnography offers a possible solution, but the cannula can become dislodged and the proceduralist's endoscope often interferes with its function. End-tidal capnography in the non-intubated patient is very insensitive to changes in minute ventilation. At best, this technology can usually assess only the presence or absence of ventilation: there is limited ability to judge the adequacy of ventilation or to quantify it.4

The Study Device The ExSpiron Respiratory Volume Monitor (Respiratory Motion, Inc., Waltham MA) has FDA 501(k) clearance to be used for patient care. It consists of a proprietary PadSet that is placed on the chest in the mid-axillary line and connected to a free standing monitor. This monitor measures and analyzes the changes in thoracic electrical impedance that occur during the respiratory duty cycle. It is able to quantify respiratory rate and also determine tidal volume and minute ventilation as well as graphically display changes in lung volumes. It has been shown to accurately measure the effect of interventions (medications, airway maneuvers) in endoscopy patients.5 Preliminary work has determined optimal lead placement demonstrated excellent correlation to spirometry with an R value of 0.94-0.98 and excellent accuracy and precision.6

Preliminary work cited below has shown that the monitor provides information about the effect of medications and airway maneuvers on breathing patterns that is not available with routine monitoring. This study seeks to extend that knowledge by investigating whether using this information in real-time results in different respiratory measurements compared to patients with routine monitoring.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Biliary Tract Diseases
  • Stomach Neoplasms
  • Carcinoma, Pancreatic Ductal
  • Barrett Esophagus
Intervention  ICMJE Device: ExSpiron Respiratory Variation Monitor
Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
Study Arms  ICMJE
  • Blinded Group
    Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
    Intervention: Device: ExSpiron Respiratory Variation Monitor
  • Experimental: Monitor Group
    The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
    Intervention: Device: ExSpiron Respiratory Variation Monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects undergoing upper gastrointestinal endoscopy

Exclusion Criteria:

  • Patients with a history of thoracotomy with resection of lung tissue
  • Patients with a history of severe chronic obstructive pulmonary disease (defined as an inability to climb a flight of stairs or FEV1/VC of less than 30% of predicted)
  • BMI greater than 43.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02310230
Other Study ID Numbers  ICMJE M14-281
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Donald Mathews, University of Vermont
Study Sponsor  ICMJE Donald Mathews
Collaborators  ICMJE Respiratory Motion, Inc.
Investigators  ICMJE
Principal Investigator: Donald M Mathews, M.D. University of Vermont
PRS Account University of Vermont
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP