Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 39 for:    FLUMAZENIL

Detecting Post-Operative Respiratory Depression in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01843933
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Melissa Langhan, Yale University

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 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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Capnography
Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion




Primary Outcome Measures :
  1. 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 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
Yale University
Thrasher Research Fund

Publications:
Layout table for additonal information
Responsible Party: Melissa Langhan, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01843933     History of Changes
Other Study ID Numbers: 1112009471
First Posted: May 1, 2013    Key Record Dates
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases