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临床试验/NCT01843933
NCT01843933已完成不适用

Detecting Post-Operative Respiratory Depression in Children: Are Our Current Standards Good Enough?

Yale University3 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
3
主要终点
Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions

研究概览

简要总结

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.

详细描述

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 monitored unit and a 4-bed perioperative area where patients receive one-on-one nursing care. Generally, between 20-30 patients are cared for in the PACU each day with a typical length of stay of approximately 2 hours.

Specific Aim 1b: To determine whether the addition of capnography will lead to a decrease in the frequency of oxygen desaturations as measured by pulse oximetry and respiratory depression in children recovering from general anesthesia.

Study Design and Setting: The investigators will conduct a randomized controlled trial in the Yale-New Haven Children's PACU.

The identical population, inclusion and exclusion criteria and recruitment procedures will apply. A random number list will again be generated to guide recruitment. Investigators will be blinded to group designation prior to consent and enrollment.

Study Intervention and Data Collection: Prior to the onset of this study, PACU nursing staff will receive focused training on the application and interpretation of capnography. Proper positioning of the nasal-oral cannula will be demonstrated. Capnography waveforms will be reviewed including normal respiratory patterns and end-tidal CO2 (ETCO2) levels that would indicate hypoventilation, apnea or obstruction. Staff will be instructed that they can provide interventions when ETCO2 values greater than 50mmHg or less than 30mmHg are obtained without a concomitant increase in respiratory rate. Simple noninvasive interventions may include reposition of the head, instructing the patient to take several deep breaths, physical stimulation, or placing a shoulder roll under the patient. Invasive interventions may include administration of reversal medications, bag-valve mask assisted ventilation, the insertion of an oral or nasal airway and endotracheal intubation. Patients who develop oxygen saturations less than 93% may receive an increased amount of supplemental oxygen at the discretion of the treating staff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions

时间窗: Post operative period (From entering the PACU until discharge. Average time is 1 hour)

Mild Events/Interventions: * 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 Events/Interventions: * 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 Events/Interventions: * 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Langhan

Principal Investigator

Yale University

研究点 (3)

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