Trial Outcomes & Findings for Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2 (NCT NCT02340299)

Results Overview

Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

64 h to 80 h

Results posted on

2020-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	nHFOV Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs	nCPAP Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs
Overall Study STARTED	4	2
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	nHFOV n=4 Participants Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs	nCPAP n=2 Participants Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=4 Participants	2 Participants n=2 Participants	6 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants
Age, Continuous	19 days n=4 Participants	16 days n=2 Participants	17.5 days n=6 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	1 Participants n=2 Participants	3 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	1 Participants n=2 Participants	3 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	4 participants n=4 Participants	2 participants n=2 Participants	6 participants n=6 Participants

PRIMARY outcome

Timeframe: 64 h to 80 h

Population: In patients that were reintubated within 72 h, the primary outcome, paCO2 72 h after extubation, could not be assessed. In the nCPAP group, all patients had to be reintubated within 72 h. The primary outcome, paCO2 72 h after extubation, could therefore only be assessed in the nHFOV group.

Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.

Outcome measures

Outcome measures
Measure	nHFOV n=2 Participants Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs	nCPAP Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs
paCO2 at 72 h After Extubation	65.5 mmHg Interval 52.0 to 79.0	—

SECONDARY outcome

Timeframe: within the first 6 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within the first 6 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within the first 6 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within the first 6 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 64-80 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 64-80 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 64-80 h after extubation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 h after extubation

Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 7 days after extubation

Defined as the number of patients reaching the criterion of "treatment failure"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 7 days after extubation

Defined as the number of patients being reintubated

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 72 hours after extubation

Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until discharge

Incidences of the following adverse effects: Intraventricular hemorrhage III°-IV° (Papile), surgical necrotizing enterocolitis, pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus requiring surgical closure, retinopathy of prematurity requiring laser treatment and/or injection of bevacizumab, death or moderate to severe bronchopulmonary dysplasia (Jobe) at 36 weeks' gestational age, periventricular leukomalacia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until discharge

Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 6 h after switch to "rescue treatment"

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 6 h after switch to "rescue treatment"

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 6 h after switch to "rescue treatment"

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 6 h after switch to "rescue treatment"

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 h after switch to "rescue" treatment

Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"

Outcome measures

Outcome data not reported

Adverse Events

nHFOV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

nCPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	nHFOV n=4 participants at risk Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs	nCPAP n=2 participants at risk Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs
Respiratory, thoracic and mediastinal disorders Highly viscous secretions	50.0% 2/4 • Number of events 2 • Adverse event data was collected until discharge from the neonatal unit. Patients were discharged approximately at 3 months of age.	0.00% 0/2 • Adverse event data was collected until discharge from the neonatal unit. Patients were discharged approximately at 3 months of age.

Additional Information

PD Dr. Christoph Czernik, principal investigator

Charité - Universitätsmedizin Berlin

Phone: +49 30 450

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place