Trial Outcomes & Findings for Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis (NCT NCT01014910)

NCT ID: NCT01014910

Last Updated: 2021-09-16

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

Summarized from admission to hospital discharge

Results posted on

2021-09-16

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	80	81
Overall Study COMPLETED	80	79
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Pulse Oximetry Monitoring n=80 Participants 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 n=81 Participants 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 n=161 Participants Total of all reporting groups
Age, Continuous	0.22 years n=99 Participants	0.30 years n=107 Participants	0.25 years n=206 Participants
Sex: Female, Male Female	41 Participants n=99 Participants	32 Participants n=107 Participants	73 Participants n=206 Participants
Sex: Female, Male Male	39 Participants n=99 Participants	49 Participants n=107 Participants	88 Participants n=206 Participants
Region of Enrollment United States	80 participants n=99 Participants	81 participants n=107 Participants	161 participants n=206 Participants
Presence of rhonorrhea	77 participants n=99 Participants	77 participants n=107 Participants	154 participants n=206 Participants
Decreased oral intake	51 participants n=99 Participants	54 participants n=107 Participants	105 participants n=206 Participants
Vomiting	32 participants n=99 Participants	40 participants n=107 Participants	72 participants n=206 Participants
Diarrhea	14 participants n=99 Participants	14 participants n=107 Participants	28 participants n=206 Participants
Rash	6 participants n=99 Participants	14 participants n=107 Participants	20 participants n=206 Participants
Irritability	29 participants n=99 Participants	27 participants n=107 Participants	56 participants n=206 Participants
Lethargy	12 participants n=99 Participants	11 participants n=107 Participants	23 participants n=206 Participants
Seizure	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
History of tobacco exposure	17 participants n=99 Participants	22 participants n=107 Participants	39 participants n=206 Participants
Family history of asthma/reactive airway disease	30 participants n=99 Participants	45 participants n=107 Participants	75 participants n=206 Participants
Day-care exposure	8 participants n=99 Participants	15 participants n=107 Participants	23 participants n=206 Participants
Receipt of bronchodilators prior to admission	58 participants n=99 Participants	63 participants n=107 Participants	121 participants n=206 Participants
Receipt of antibiotics prior to admission	10 participants n=99 Participants	21 participants n=107 Participants	31 participants n=206 Participants
Receipt of oral corticosteroids before admission	4 participants n=99 Participants	12 participants n=107 Participants	16 participants n=206 Participants

PRIMARY outcome

Timeframe: Summarized from admission to hospital discharge

Outcome measures

Outcome measures
Measure	Continuous Pulse Oximetry Monitoring n=80 Participants 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 n=81 Participants 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.
Length of Stay in the Hospital	38.7 hours Interval 23.6 to 64.7	39.5 hours Interval 24.3 to 59.5

SECONDARY outcome

Timeframe: Summarized from admission to hospital discharge

Outcome measures

Outcome measures
Measure	Continuous Pulse Oximetry Monitoring n=80 Participants 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 n=81 Participants 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.
Clinical Deterioration Necessitating Transfer to Higher Level of Care	4 participants	4 participants

Adverse Events

Continuous Pulse Oximetry Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermittent Pulse Oximetry Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Russell McCulloh

Children's Mercy Hospital Kansas City

Phone: 816-234-3061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place