Delivery Room Resuscitation
Conditions
Keywords
ventilation, end tidal carbon dioxide, hypercapnia, hypocapnia, positive pressure ventilation, neonates, delivery room resuscitation
Brief summary
This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.
Interventions
DEVICEEnd 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.
Sponsors
Neil Finer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Minutes
Healthy volunteers
No
Inclusion criteria
* Need for ventilation in the delivery room
Exclusion criteria
* Tracheal suctioning for meconium * Congenital Diaphragmatic Hernia * Suspected hypoplasia of the lungs * Oligohydramnios \<28 weeks gestation or AFI\<5 * Known or suspected airway anomaly * Mother not speaking English or Spanish * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCO2 Level Outside of Desired Range (40-60 mmHg) | Admission to NICU, approximately 1 hour of life | This outcome will be obtained from the first available blood gas after admission to the NICU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End Tidal CO2 Levels | 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. |
| Oxygen Use at 36 Weeks | Hospital course, approximately 2-3 months | This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age. |
| Duration of Ventilation | 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. |
| Number of Patients Ventilated on NICU Admission | On NICU admission, approximately 15 minutes of life | At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group |
| Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow | Within 12 hours of life | An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow. |
| Incidence of Pneumothorax/Airleak | 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. |
Countries
United States
Participant flow
Pre-assignment details
50 participants were randomized however one participants randomization assignment was undocumented, so 49 participants are accounted for.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Control Arm | Monitored Arm |
|---|---|---|---|
| 5 mim Apgar < 5 | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized Age ( Gestational Age , weeks and range | 29.2 weeks | 29.3 weeks | 28.9 weeks |
| Antenatal Steroids | 46 Participants | 23 Participants | 23 Participants |
| Cord PCO2 (mmHg) | 51 mmHg | 50 mmHg | 52 mmHg |
| DR CPR | 0 Participants | 0 Participants | 0 Participants |
| DR Intubation | 7 Participants | 4 Participants | 3 Participants |
| Mode of Delivery - Cesarean Section | 36 Participants | 17 Participants | 19 Participants |
| NICU Intubation | 19 Participants | 10 Participants | 9 Participants |
| Rec'd Surfactant | 25 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Female | 30 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Male | 18 Participants | 12 Participants | 6 Participants |
| Twin | 11 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 24 | 1 / 24 |
| other Total, other adverse events | 2 / 24 | 2 / 24 |
| serious Total, serious adverse events | 2 / 24 | 1 / 24 |
Outcome results
Primary
PCO2 Level Outside of Desired Range (40-60 mmHg)
This outcome will be obtained from the first available blood gas after admission to the NICU.
Time frame: Admission to NICU, approximately 1 hour of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monitored Arm | PCO2 Level Outside of Desired Range (40-60 mmHg) | 9 participants |
| Control Arm | PCO2 Level Outside of Desired Range (40-60 mmHg) | 8 participants |
Secondary
Duration of Ventilation
The number of days on the ventilator during the entire hospital course will be counted for this outcome.
Time frame: Duration of the hospital course, approximately 2-3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Monitored Arm | Duration of Ventilation | 1 days |
| Control Arm | Duration of Ventilation | 1.5 days |
Secondary
End Tidal CO2 Levels
The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.
Time frame: At the conclusion of resuscitation, approximately 15 minutes of life.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Monitored Arm | End Tidal CO2 Levels | 42.8 mmHg |
| Control Arm | End Tidal CO2 Levels | 44.3 mmHg |
Secondary
Incidence of Pneumothorax/Airleak
This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.
Time frame: Hospital course, approximately 2-3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monitored Arm | Incidence of Pneumothorax/Airleak | 2 Participants |
| Control Arm | Incidence of Pneumothorax/Airleak | 2 Participants |
Secondary
Number of Patients Ventilated on NICU Admission
At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group
Time frame: On NICU admission, approximately 15 minutes of life
Population: Only 7 patients were ventilated on admission to the NICU- data not presented
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monitored Arm | Number of Patients Ventilated on NICU Admission | 3 Participants |
| Control Arm | Number of Patients Ventilated on NICU Admission | 4 Participants |
Secondary
Oxygen Use at 36 Weeks
This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.
Time frame: Hospital course, approximately 2-3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monitored Arm | Oxygen Use at 36 Weeks | 3 Participants |
| Control Arm | Oxygen Use at 36 Weeks | 2 Participants |
Secondary
Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow
An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.
Time frame: Within 12 hours of life
Population: The echocardiograms were not performed on all patients because of lack of available staff
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monitored Arm | Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow | 83.7 ml/kg/min | Standard Deviation 43.1 |
| Control Arm | Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow | 92.2 ml/kg/min | Standard Deviation 42.3 |