Trial Outcomes & Findings for Detecting Post-Operative Respiratory Depression in Children (NCT NCT01843933)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

211 participants

Primary outcome timeframe

Post operative period (From entering the PACU until discharge. Average time is 1 hour)

Results posted on

2016-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Control: Standard Monitoring and Blinded to Capnography 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.	Intervention: Standard Monitoring and Capnography Viewable 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 Study STARTED	104	107
Overall Study COMPLETED	98	103
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Control: Standard Monitoring and Blinded to Capnography 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.	Intervention: Standard Monitoring and Capnography Viewable 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 Study Data lost	6	4

Baseline Characteristics

Detecting Post-Operative Respiratory Depression in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control: Standard Monitoring and Blinded to Capnography n=98 Participants 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.	Intervention: Standard Monitoring and Capnography Viewable n=103 Participants 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 n=201 Participants Total of all reporting groups
Age, Continuous	10.4 years STANDARD_DEVIATION 5.1 • n=5 Participants	10.1 years STANDARD_DEVIATION 5.4 • n=7 Participants	10.2 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	59 Participants n=7 Participants	113 Participants n=5 Participants
Race/Ethnicity, Customized White	60 participants n=5 Participants	65 participants n=7 Participants	125 participants n=5 Participants
Race/Ethnicity, Customized Black	10 participants n=5 Participants	17 participants n=7 Participants	27 participants n=5 Participants
Race/Ethnicity, Customized Other	28 participants n=5 Participants	21 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Post operative period (From entering the PACU until discharge. Average time is 1 hour)

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

Outcome measures

Outcome measures
Measure	Control: Standard Monitoring and Blinded to Capnography n=98 Participants 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.	Intervention: Standard Monitoring and Capnography Viewable n=103 Participants 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.
Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions Abnormal ETCO2	56 participants	58 participants
Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions Abnormal Pulse Oximetry	8 participants	15 participants
Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions Staff interventions	20 participants	20 participants

Adverse Events

Control: Standard Monitoring and Blinded to Capnography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention: Standard Monitoring and Capnography Viewable

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

Melissa Langhan

Yale University

Phone: 2037377413

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place