Trial Outcomes & Findings for Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness (NCT NCT04407806)

Results Overview

The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Duration of length of stay, up to 14 days

Results posted on

2022-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Pulse Oximetry Monitoring of Oxygen Saturation Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization	Intermittent Pulse Oximetry Monitoring of Oxygen Saturation Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Overall Study STARTED	3	3
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Pulse Oximetry Monitoring of Oxygen Saturation Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization	Intermittent Pulse Oximetry Monitoring of Oxygen Saturation Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Pulse Oximetry Monitoring of Oxygen Saturation n=3 Participants Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization	Intermittent Pulse Oximetry Monitoring of Oxygen Saturation n=3 Participants Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization	Total n=6 Participants Total of all reporting groups
Age, Continuous	10 years n=3 Participants	1.64 years n=3 Participants	6.15 years n=6 Participants
Sex: Female, Male Female	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	3 participants n=3 Participants	6 participants n=6 Participants

PRIMARY outcome

Timeframe: Duration of length of stay, up to 14 days

The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.

Outcome measures

Outcome measures
Measure	Continuous Pulse Oximetry Monitoring of Oxygen Saturation n=3 Participants Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization	Intermittent Pulse Oximetry Monitoring of Oxygen Saturation n=3 Participants Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Length of Stay, Measured in Days	1.15 days Standard Deviation .20	1.04 days Standard Deviation .54

SECONDARY outcome

Timeframe: On day of hospital discharge, up to 14 days

Population: Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment. Parents were not considered enrolled but did contribute to this assessment.

Parental rating of care received in hospital, as measured by "Parent Study Questionnaire",using Likert scale, where 5 represents "My child received excellent care" and 1 represents "My child received very poor care". A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	Continuous Pulse Oximetry Monitoring of Oxygen Saturation n=2 Participants Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization	Intermittent Pulse Oximetry Monitoring of Oxygen Saturation n=1 Participants Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Comfort of Parents: Level of Care Their Child Received in Hospital	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: On day of hospital discharge, up to 14 days

Population: Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment.

Comfort level of parents as measured by "Parent Study Questionnaire", using Likert scale where 5 represents "very comfortable with continuing to care for child at home" and 1 represents "very uncomfortable with continuing care for child at home." A higher score represents a better outcome

Outcome measures

Outcome measures
Measure	Continuous Pulse Oximetry Monitoring of Oxygen Saturation n=2 Participants Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization	Intermittent Pulse Oximetry Monitoring of Oxygen Saturation n=1 Participants Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Comfort of Parents: Continuing to Care for Their Child at Home	5 score on a scale Interval 5.0 to 5.0	3 score on a scale Interval 3.0 to 3.0

SECONDARY outcome

Timeframe: Duration of length of stay, up to 14 days

Population: Data was not collected, data was not analyzed for any participants.

Number of times nurses respond to pulse oximetry alarms, tabulated per patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of length of stay, up to 14 days

Population: Data was not collected, data was not analyzed for any participants.

Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient

Outcome measures

Outcome data not reported

Adverse Events

Continuous Pulse Oximetry Monitoring of Oxygen Saturation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermittent Pulse Oximetry Monitoring of Oxygen Saturation

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. Graham Krasan, Pediatric Infectious Disease Specialist

William Beaumont Hospital

Phone: 248-551-0046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place