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Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

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ClinicalTrials.gov Identifier: NCT01014910
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
Baylor University
Lifespan
University of Missouri, Kansas City
Information provided by (Responsible Party):
Russell McCulloh, Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Bronchiolitis
Hypoxia
Interventions Other: Continuous pulse oximetry monitoring
Device: Intermittent pulse oximetry monitoring
Enrollment 161
Recruitment Details 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 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.
Arm/Group Title Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 80 81
Completed 80 79
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 80 81 161
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 80 participants 81 participants 161 participants
0.22
(0.13 to 0.44)
0.30
(0.15 to 0.64)
0.25
(0.13 to 0.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
Female
41
  51.2%
32
  39.5%
73
  45.3%
Male
39
  48.8%
49
  60.5%
88
  54.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 81 participants 161 participants
80 81 161
Presence of rhonorrhea  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
77 77 154
Decreased oral intake  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
51 54 105
Vomiting  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
32 40 72
Diarrhea  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
14 14 28
Rash  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
6 14 20
Irritability  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
29 27 56
Lethargy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
12 11 23
Seizure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
0 0 0
History of tobacco exposure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
17 22 39
Family history of asthma/reactive airway disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
30 45 75
Day-care exposure   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
8 15 23
[1]
Measure Description: Includes patients with a sibling in daycare
Receipt of bronchodilators prior to admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
58 63 121
Receipt of antibiotics prior to admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
10 21 31
Receipt of oral corticosteroids before admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 81 participants 161 participants
4 12 16
1.Primary Outcome
Title Length of Stay in the Hospital
Hide Description [Not Specified]
Time Frame Summarized from admission to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 80 81
Median (Inter-Quartile Range)
Unit of Measure: hours
38.7
(23.6 to 64.7)
39.5
(24.3 to 59.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Pulse Oximetry Monitoring, Intermittent Pulse Oximetry Monitoring
Comments Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.
Method Wilcoxon (Mann-Whitney)
Comments Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)
2.Secondary Outcome
Title Clinical Deterioration Necessitating Transfer to Higher Level of Care
Hide Description [Not Specified]
Time Frame Summarized from admission to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 80 81
Measure Type: Number
Unit of Measure: participants
4 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Pulse Oximetry Monitoring, Intermittent Pulse Oximetry Monitoring
Comments The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame Data on adverse events were collected for the period of the patient's hospital stay as well as documentation of any hospital readmissions within 14 days of discharge from the hospital. No contact with patient families was made after hospital discharge.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/81 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Pulse Oximetry Monitoring Intermittent Pulse Oximetry Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/81 (0.00%) 
Our study was not designed or powered to detect differences in ICU transfers.
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: Dr. Russell McCulloh
Organization: Children's Mercy Hospital Kansas City
Phone: 816-234-3061
EMail: rmcculloh@cmh.edu
Publications:
Layout table for additonal information
Responsible Party: Russell McCulloh, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01014910     History of Changes
Other Study ID Numbers: CMTT# 4151-09
First Submitted: November 16, 2009
First Posted: November 17, 2009
Results First Submitted: January 26, 2016
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016