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Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

This study has been completed.
Sponsor:
Collaborators:
Baylor University
Lifespan
University of Missouri, Kansas City
Information provided by (Responsible Party):
Russell McCulloh, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01014910
First received: November 16, 2009
Last updated: February 22, 2016
Last verified: February 2016
Results First Received: January 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Bronchiolitis
Hypoxia
Interventions: Other: Continuous pulse oximetry monitoring
Device: Intermittent pulse oximetry monitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from October 2009 to April 2014. Only 1 study site used an institutional clinical practice guideline during the study. Respiratory-distress scoring systems for hospitalized patients were not standardized across sites. All sites used an oxygen saturation level of 90% or higher in room air as a criterion for hospital discharge.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were sequentially randomized at each site in strict chronological order of hospital admission each day. Screening of participants was performed on weekdays during normal business hours. only. Parents/guardians were blinded to allocation assignment until informed consent was obtained; study personnel and outcome assessors were not.

Reporting Groups
  Description
Continuous Pulse Oximetry Monitoring

Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.

Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.

Intermittent Pulse Oximetry Monitoring

Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.

Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.


Participant Flow:   Overall Study
    Continuous Pulse Oximetry Monitoring   Intermittent Pulse Oximetry Monitoring
STARTED   80   81 
COMPLETED   80   79 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Continuous Pulse Oximetry Monitoring

Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.

Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.

Intermittent Pulse Oximetry Monitoring

Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.

Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.

Total Total of all reporting groups

Baseline Measures
   Continuous Pulse Oximetry Monitoring   Intermittent Pulse Oximetry Monitoring   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   81   161 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 0.22 
 (0.13 to 0.44) 
 0.30 
 (0.15 to 0.64) 
 0.25 
 (0.13 to 0.52) 
Gender 
[Units: Participants]
     
Female   41   32   73 
Male   39   49   88 
Region of Enrollment 
[Units: Participants]
     
United States   80   81   161 
Presence of rhonorrhea 
[Units: Participants]
 77   77   154 
Decreased oral intake 
[Units: Participants]
 51   54   105 
Vomiting 
[Units: Participants]
 32   40   72 
Diarrhea 
[Units: Participants]
 14   14   28 
Rash 
[Units: Participants]
 6   14   20 
Irritability 
[Units: Participants]
 29   27   56 
Lethargy 
[Units: Participants]
 12   11   23 
Seizure 
[Units: Participants]
 0   0   0 
History of tobacco exposure 
[Units: Participants]
 17   22   39 
Family history of asthma/reactive airway disease 
[Units: Participants]
 30   45   75 
Day-care exposure [1] 
[Units: Participants]
 8   15   23 
[1] Includes patients with a sibling in daycare
Receipt of bronchodilators prior to admission 
[Units: Participants]
 58   63   121 
Receipt of antibiotics prior to admission 
[Units: Participants]
 10   21   31 
Receipt of oral corticosteroids before admission 
[Units: Participants]
 4   12   16 


  Outcome Measures
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1.  Primary:   Length of Stay in the Hospital   [ Time Frame: Summarized from admission to hospital discharge ]

2.  Secondary:   Clinical Deterioration Necessitating Transfer to Higher Level of Care   [ Time Frame: Summarized from admission to hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study was not designed or powered to detect differences in ICU transfers.


  More Information
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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:  
Name/Title: Dr. Russell McCulloh
Organization: Children's Mercy Hospital Kansas City
phone: 816-234-3061
e-mail: rmcculloh@cmh.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Russell McCulloh, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01014910     History of Changes
Other Study ID Numbers: CMTT# 4151-09
Study First Received: November 16, 2009
Results First Received: January 26, 2016
Last Updated: February 22, 2016
Health Authority: United States: Institutional Review Board