Detecting Post-Operative Respiratory Depression in Children
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|ClinicalTrials.gov Identifier: NCT01843933|
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Depression||Device: Capnography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detecting Post-Operative Respiratory Depression in Children: Are Our Current Standards Good Enough?|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: Standard monitoring and blinded to capnography
Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
Active Comparator: Capnography
Capnography will be added to standard monitoring practices. A portable capnography monitor (Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion) will be used to collect and record data.
Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion
- Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions [ Time Frame: Post operative period (From entering the PACU until discharge. Average time is 1 hour) ]
- Mild oxygen desaturation: Pulse oximetry < 93% on room air or <95% on oxygen
- Hypopneic hypoventilation: ETCO2 values < 30mmHg for >30 seconds
- Bradypneic hypoventilation: ETCO2 values > 50mmHg for >30 seconds
- Stimulation: Verbally or physical stimulation to encourage breathing
- Moderate oxygen desaturation: Pulse oximetry < 85% on room air or <90% on oxygen
- Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for >20 seconds
- Airway obstruction: ETCO2 value of 0mmHg without cessation of respiratory effort
- Airway repositioning: Jaw thrust or chin lift or use of a shoulder roll
- Airway adjunct: Oral or nasal airway device
- Severe oxygen desaturation: Pulse oximetry < 80% on room air or <85% on oxygen
- Assisted ventilation: Use of a bag-valve mask, a laryngeal mask airway or endotracheal intubation
- Reversal medications: Use of naloxone or flumazenil
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): NCT01843933
|United States, Connecticut|
|Yale-New Haven Children's Hospital|
|New Haven, Connecticut, United States, 06510|
|Yale-New Haven Children's Hospital|
|New Haven, Connecticut, United States, 06511|