N/A
N=211
Detecting Post-Operative Respiratory Depression in Children
Respiratory Depression
Bottom Line
View on ClinicalTrials.gov: NCT01843933 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions — 56; 58; 8; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capnography (Device)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions |
56; 58; 8; 15; 20; 20 | — |
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 there are less data specific to children, in general 25% of patients in the recovery room experience complications from anesthesia. The most common complications involve the patient's airway and their ability to breath adequately. Currently, checks of oxygenation with a pulse oximetry monitor and of respiration through nursing assessments are used to detect breathing problems. However, these are believed not to be adequate for reliably recognizing significant respiratory depression until other dangerous events develop such as the cessation of breathing, severe drops in oxygen levels, or cardiac arrest. Capnography is a monitoring device that measures the amount of carbon dioxide being exhaled and assesses the adequacy of respiration. A small plastic cannula sits at the base of the nose and on the lip to continuously monitor the patient's breathing. Most children tolerate this device well and staff consider it easy to use. While capnography is routinely used in the operating room to monitor breathing, it is not used during post-operative care when patients are still at risk of breathing problems.
Objectives: To determine if capnography can detect problems with breathing faster and more often than traditional monitors. To determine if the addition of capnography to routine monitoring will decrease the numbers of additional adverse events that occur in children undergoing post-operative care by allowing nurses to intervene in care faster and more frequently.
Methods: In the first phase of this study, the investigators will apply the capnography monitor to children in the recover room and determine how often they experience breathing difficulties measured by this device. In the second phase, the investigators will educate staff on the use of capnography and what values are considered abnormal. Children will again have the capnography cannula placed on them as they enter the recovery room. They will then be divided into two groups - in one group the nurses in the recovery room will have access to the capnography monitor for their patients, whereas in the other group the nurses will not be able to see the readout from the monitor. The investigators will determine if children have fewer breathing problems and less additional adverse events when nurses use capnography in addition to the routine monitors already in place in the recovery room as compared to when nurses use standard monitoring alone.
Potential Impact: If capnography can detect breathing problems prior to being identified by current monitoring devices, staff may be able to intervene more quickly and before more serious events occur in the children receiving post-operative care. This can reduce adverse events, improve patient safety, and avert harm in children. The adoption of this device for routine monitoring of post-operative care has the potential to save lives.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01843933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.