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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

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.


Condition or disease Intervention/treatment Phase
Biliary Tract Diseases Stomach Neoplasms Carcinoma, Pancreatic Ductal Barrett Esophagus Device: ExSpiron Respiratory Variation Monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy
Study Start Date : September 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.
Device: ExSpiron Respiratory Variation Monitor
Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.

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.
Device: ExSpiron Respiratory Variation Monitor
Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of airway maneuvers required to maintain ventilation in each group [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  2. Effectiveness of airway maneuvers in each group (change in minute ventilation) [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  3. 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 ]
  4. Incidence of hypopnea in each group [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  5. Average oxygen saturation between the two groups [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  6. Percentage of time with oxygenation less than 90% between the two groups [ Time Frame: Duration of procedure: Approximately 60 minutes ]
  7. The ability of respiratory parameters with capnography to assess states of hypoventilation between the two groups [ Time Frame: Duration of procedure: Approximately 60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310230


Contacts
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Contact: Alexander Friend, M.S. 802-847-4259 alexander.friend@vtmednet.org

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Alexander Friend, M.S.    802-847-4259    alexander.friend@vtmednet.org   
Principal Investigator: Donald M Mathews, M.D.         
Sponsors and Collaborators
Donald Mathews
Respiratory Motion, Inc.
Investigators
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Principal Investigator: Donald M Mathews, M.D. University of Vermont
Publications:
Holley K, Mathews D, Freeman J, Brayanov J, Schapiro H. The Use of a Respiratory Volume Monitor to Assess Ventilation Before & After Airway Maneuvers during Upper Endoscopy. Poster Presentation, American Society of Anesthesiologists, October 2013, San Francisco, CA
Freeman J, Lalli M, Yocum N, Panasyuk A, Panasyuk S, and Lew R, 328: Non-invasive Monitoring of Tidal Volume and Minute Ventilation in Non-intubated Patients. Critical Care Medicine, 2011. 39(12): p. 88 10.1097/01.ccm.0000408627.24229.88.

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Responsible Party: Donald Mathews, Attending Anesthesiologist and Professor of Anesthesiology, University of Vermont
ClinicalTrials.gov Identifier: NCT02310230    
Other Study ID Numbers: M14-281
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Donald Mathews, University of Vermont:
Endoscopy, Upper
Minute Ventilation
Tidal Volume
Respiratory Rate
Additional relevant MeSH terms:
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Barrett Esophagus
Stomach Neoplasms
Carcinoma, Pancreatic Ductal
Biliary Tract Diseases
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Stomach Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases