Evaluation of Respiratory Acoustic Monitor in Children After Surgery

NCT02256384 | Completed Results

• 1 other identifier: 2014-6421
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

Conditions

Respiratory Complications; Pediatric

Keywords

Respiration Rate; Respiratory Acoustic Monitor; postoperative

Outcome Measures

Primary Outcomes (1)

• Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)

  The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute. The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.

  Up to 24 hours after surgery

Secondary Outcomes (2)

• Presence of False Alarms

  Up to 24 hours after surgery

• Tolerance of the RAM

  Up to 24 hours after surgery

Study Arms (1)

Respiratory Acoustic Monitoring

EXPERIMENTAL

All participants will wear the respiratory acoustic monitoring device.

Device: Respiratory Acoustic Monitor

Interventions

Respiratory Acoustic Monitor DEVICE

Examine the reliability and accuracy of the respiratory acoustic monitor.

Respiratory Acoustic Monitoring

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female children 2 to 16 years of age
• In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
• Child weighs at least 10 kg on day of surgery

You may not qualify if:

• Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
• Patient is admitted to the Intensive Care Unit
• Patient has tracheostomy
• Patient is on non-invasive ventilator support

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Masimo Corporation: collaborator
• Children's Medical Center Dallas: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

UT Southwestern Medical Center - Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.

  PMID: 28448390 RESULT

Results Point of Contact

• Title: Mario Patino
• Organization: Cincinnati Children's Hospital Medical Center

mario.patino@cchmc.org

513-636-4200

Study Officials

• Mario Patino, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Peter Szmuk, MD

  UT Southwestern Medical Center- Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Locations

US (2)