Trial Outcomes & Findings for Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR) (NCT NCT01381068)

NCT ID: NCT01381068

Last Updated: 2019-12-17

Results Overview

This outcome will be obtained from the first available blood gas after admission to the NICU.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Admission to NICU, approximately 1 hour of life
• Results posted on: 2019-12-17

Participant Flow

50 participants were randomized however one participants randomization assignment was undocumented, so 49 participants are accounted for.

Participant milestones

Measure	Monitored Arm The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Overall Study STARTED	25	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Monitored Arm The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Overall Study Death	1	0

Baseline Characteristics

Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)

Baseline characteristics by cohort

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Total n=48 Participants Total of all reporting groups
Age, Customized Age ( Gestational Age , weeks and range	28.9 weeks n=5 Participants	29.3 weeks n=7 Participants	29.2 weeks n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Antenatal Steroids	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Mode of Delivery - Cesarean Section	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
5 mim Apgar < 5	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Twin	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
DR Intubation	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
NICU Intubation	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
DR CPR	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Cord PCO2 (mmHg)	52 mmHg n=5 Participants	50 mmHg n=7 Participants	51 mmHg n=5 Participants
Rec'd Surfactant	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Admission to NICU, approximately 1 hour of life

This outcome will be obtained from the first available blood gas after admission to the NICU.

Outcome measures

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
PCO2 Level Outside of Desired Range (40-60 mmHg)	9 participants	8 participants

SECONDARY outcome

Timeframe: At the conclusion of resuscitation, approximately 15 minutes of life.

The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.

Outcome measures

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
End Tidal CO2 Levels	42.8 mmHg Interval 29.0 to 59.0	44.3 mmHg Interval 16.0 to 66.0

SECONDARY outcome

Timeframe: Duration of the hospital course, approximately 2-3 months

The number of days on the ventilator during the entire hospital course will be counted for this outcome.

Outcome measures

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Duration of Ventilation	1 days Interval 0.0 to 30.0	1.5 days Interval 0.0 to 38.0

SECONDARY outcome

Timeframe: Hospital course, approximately 2-3 months

This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.

Outcome measures

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Oxygen Use at 36 Weeks	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Hospital course, approximately 2-3 months

This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.

Outcome measures

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Incidence of Pneumothorax/Airleak	2 Participants	2 Participants

SECONDARY outcome

Timeframe: On NICU admission, approximately 15 minutes of life

Population: Only 7 patients were ventilated on admission to the NICU- data not presented

At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group

Outcome measures

Measure	Monitored Arm n=24 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Number of Patients Ventilated on NICU Admission	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Within 12 hours of life

Population: The echocardiograms were not performed on all patients because of lack of available staff

An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.

Outcome measures

Measure	Monitored Arm n=16 Participants The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=15 Participants The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow	83.7 ml/kg/min Standard Deviation 43.1	92.2 ml/kg/min Standard Deviation 42.3

Adverse Events

Monitored Arm

Serious events: 2 serious events

Other events: 2 other events

Deaths: 3 deaths

Control Arm

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Monitored Arm n=24 participants at risk The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 participants at risk The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Nervous system disorders Severe IVH or PVL	8.3% 2/24 • Number of events 2	4.2% 1/24 • Number of events 1

Other adverse events

Measure	Monitored Arm n=24 participants at risk The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.	Control Arm n=24 participants at risk The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. End tidal CO2 monitor: The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
Respiratory, thoracic and mediastinal disorders air leak	8.3% 2/24	8.3% 2/24

Additional Information

Neil Finer

UCSD

Email: nfiner@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place