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Trial record 33 of 39 for:    FLUMAZENIL

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
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Melissa Langhan, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Respiratory Depression
Intervention Device: Capnography
Enrollment 211
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable
Hide Arm/Group Description Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. 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. Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
Period Title: Overall Study
Started 104 107
Completed 98 103
Not Completed 6 4
Reason Not Completed
Data lost             6             4
Arm/Group Title Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable Total
Hide Arm/Group Description Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. 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. Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data. Total of all reporting groups
Overall Number of Baseline Participants 98 103 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 103 participants 201 participants
10.4  (5.1) 10.1  (5.4) 10.2  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 103 participants 201 participants
Female
44
  44.9%
44
  42.7%
88
  43.8%
Male
54
  55.1%
59
  57.3%
113
  56.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants 103 participants 201 participants
White 60 65 125
Black 10 17 27
Other 28 21 49
1.Primary Outcome
Title Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions
Hide Description

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
Time Frame Post operative period (From entering the PACU until discharge. Average time is 1 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable
Hide Arm/Group Description:
Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. 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.
Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
Overall Number of Participants Analyzed 98 103
Measure Type: Number
Unit of Measure: participants
Abnormal ETCO2 56 58
Abnormal Pulse Oximetry 8 15
Staff interventions 20 20
Time Frame Data were collected from the time of arrival to the PACU to the time of discharge. This was on average 1 hour.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable
Hide Arm/Group Description Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. 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. Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
All-Cause Mortality
Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/103 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control: Standard Monitoring and Blinded to Capnography Intervention: Standard Monitoring and Capnography Viewable
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/103 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Langhan
Organization: Yale University
Phone: 2037377413
EMail: melissa.langhan@yale.edu
Layout table for additonal information
Responsible Party: Melissa Langhan, Yale University
ClinicalTrials.gov Identifier: NCT01843933     History of Changes
Other Study ID Numbers: 1112009471
First Submitted: March 29, 2013
First Posted: May 1, 2013
Results First Submitted: December 14, 2015
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016