Status:
COMPLETED
Detecting Post-Operative Respiratory Depression in Children
Lead Sponsor:
Yale University
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Respiratory Depression
Eligibility:
All Genders
1-20 years
Phase:
NA
Brief Summary
Background: Due to the lingering effects of general anesthesia and the administration of medications for pain after surgery, children in the recovery room are at risk for breathing problems. While the...
Detailed Description
Study Site: Children will be enrolled in the post-anesthesia care unit (PACU) at Yale-New Haven Children's Hospital, where capnography is not currently utilized. The pediatric PACU is a 12-bed monitor...
Eligibility Criteria
Inclusion
- Inclusion:
- Pediatric patients (1-20yo) undergoing a scheduled, elective procedure at Yale-New Haven Hospital.
- An English-speaking parent or guardian must be present in the pre-operative care area in order to provide informed consent.
- Exclusion:
- Currently or expected to receive post-operative assisted ventilation via an endotracheal tube (ex. major cardiac surgery) or tracheostomy
- Being directly admitted to the Pediatric Intensive Care Unit or pediatric ward instead of the PACU
- Undergoing urgent or emergent surgical procedures (i.e. non-elective) or surgery that will preclude the use of a nasal-oral cannula (ex. facial reconstruction)
- Any disease or state that may lead to abnormal ETCO2 values or baseline abnormalities in pulse oximetry. These would include evidence of active asthma exacerbation such as wheeze, diabetic ketoacidosis, moderate to severe dehydration, cardiac abnormalities, severe lung disease, and major trauma as the reason for surgery.
- Inability to tolerate the nasal-oral cannula, if it is removed during the study period by the patient or family, or if subjects cry continuously during the study, which inhibits accurate readings on the monitor.
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT01843933
Start Date
June 1 2013
End Date
December 1 2014
Last Update
February 24 2016
Active Locations (2)
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1
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States, 06510
2
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States, 06511