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

NCT02310230 | Completed Results

• 1 other identifier: M14-281
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Diseases; Stomach Neoplasms; Carcinoma, Pancreatic Ductal; Barrett Esophagus

Keywords

Endoscopy, Upper; Minute Ventilation; Tidal Volume; Respiratory Rate

Outcome Measures

Primary Outcomes (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

  Minute ventilation (or respiratory minute volume) is defined as the volume of air that can be inhaled or exhaled during one minute. The ExSpiron Respiratory Variation Monitor is able to quantify respiratory rate and also determine tidal volume and minute ventilation. The monitor measures a patient's baseline minute ventilation (MV) at the beginning of the case, and then compares subsequent minute volumes to that baseline, measured as a percentage of the baseline. In that respect, the minute ventilation (MV) values can often exceed 100 percent.

  Duration of procedure: Approximately 60 minutes

Secondary Outcomes (2)

• Incidence of Airway Maneuvers Required to Maintain Ventilation in Each Group

  Duration of procedure: Approximately 60 minutes

• Time With Low Minute Ventilation

  Duration of Procedure: Approximately 60 Minutes

Study Arms (2)

Blinded Group

OTHER

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

Monitor Group

EXPERIMENTAL

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

Interventions

ExSpiron Respiratory Variation Monitor DEVICE

Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.

Blinded Group; Monitor Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing upper gastrointestinal endoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Donald Mathews: lead
• Respiratory Motion, Inc.: collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (6)

• Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.

  PMID: 16436839 BACKGROUND

• Metzner J, Posner KL, Domino KB. The risk and safety of anesthesia at remote locations: the US closed claims analysis. Curr Opin Anaesthesiol. 2009 Aug;22(4):502-8. doi: 10.1097/ACO.0b013e32832dba50.

  PMID: 19506473 BACKGROUND

• LaPierre CD, Johnson KB, Randall BR, White JL, Egan TD. An exploration of remifentanil-propofol combinations that lead to a loss of response to esophageal instrumentation, a loss of responsiveness, and/or onset of intolerable ventilatory depression. Anesth Analg. 2011 Sep;113(3):490-9. doi: 10.1213/ANE.0b013e318210fc45. Epub 2011 Mar 17.

  PMID: 21415430 BACKGROUND

• 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

  BACKGROUND

• Voscopoulos C, Brayanov J, Ladd D, Lalli M, Panasyuk A, Freeman J. Special article: evaluation of a novel noninvasive respiration monitor providing continuous measurement of minute ventilation in ambulatory subjects in a variety of clinical scenarios. Anesth Analg. 2013 Jul;117(1):91-100. doi: 10.1213/ANE.0b013e3182918098. Epub 2013 Jun 3.

  PMID: 23733842 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Biliary Tract Diseases; Stomach Neoplasms; Carcinoma, Pancreatic Ductal; Barrett Esophagus

Condition Hierarchy (Ancestors)

Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; 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; Precancerous Conditions; Esophageal Diseases

Results Point of Contact

• Title: Alexander Friend, Clinical Research Coordinator
• Organization: University of Vermont Medical Center

alexander.friend@uvmhealth.org

802-847-4259

Study Officials

• Donald M Mathews, M.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist and Professor of Anesthesiology

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: December 8, 2014
• Study Start: September 22, 2014
• Primary Completion: May 9, 2016
• Study Completion: May 9, 2016
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)