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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitored Arm | Experimental | 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. |
|
| Control Arm | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| End tidal CO2 monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Admission to NICU, approximately 1 hour of life |
| Measure | Description | Time Frame |
|---|---|---|
| End Tidal CO2 Levels | The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome. | At the conclusion of resuscitation, approximately 15 minutes of life. |
| Duration of Ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina A Leone, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
50 participants were randomized however one participants randomization assignment was undocumented, so 49 participants are accounted for.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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50 participants were randomized however one participants randomization assignment was undocumented and one participant died, so the results are being recorded for 48 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Admission to NICU, approximately 1 hour of life |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe IVH or PVL | Nervous system disorders | Systematic Assessment | severe intracranial hemorrhage or Periventricular Leukomalacia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| air leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | an air leak is a pneumothorax |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Finer | UCSD | nfiner@ucsd.edu |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D006935 | Hypercapnia |
| D016857 | Hypocapnia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The number of days on the ventilator during the entire hospital course will be counted for this outcome.
| Duration of the hospital course, approximately 2-3 months |
| Oxygen Use at 36 Weeks | This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age. | Hospital course, approximately 2-3 months |
| 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. | Hospital course, approximately 2-3 months |
| 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 | On NICU admission, approximately 15 minutes of life |
| 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. | Within 12 hours of life |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Antenatal Steroids | Count of Participants | Participants |
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| Mode of Delivery - Cesarean Section | Count of Participants | Participants |
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| 5 mim Apgar < 5 | Count of Participants | Participants |
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| Twin | Count of Participants | Participants |
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| DR Intubation | Count of Participants | Participants |
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| NICU Intubation | Count of Participants | Participants |
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| DR CPR | Count of Participants | Participants |
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| Cord PCO2 (mmHg) | Mean | Full Range | mmHg |
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| Rec'd Surfactant | Count of Participants | 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.
|
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| Secondary | End Tidal CO2 Levels | The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome. | Posted | Mean | Full Range | mmHg | At the conclusion of resuscitation, approximately 15 minutes of life. |
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| Secondary | Duration of Ventilation | The number of days on the ventilator during the entire hospital course will be counted for this outcome. | Posted | Mean | Full Range | days | Duration of the hospital course, approximately 2-3 months |
|
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| Secondary | Oxygen Use at 36 Weeks | This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age. | Posted | Count of Participants | Participants | Hospital course, approximately 2-3 months |
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| 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. | Posted | Count of Participants | Participants | Hospital course, approximately 2-3 months |
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| 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 | Only 7 patients were ventilated on admission to the NICU- data not presented | Posted | Count of Participants | Participants | On NICU admission, approximately 15 minutes of life |
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| 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. | The echocardiograms were not performed on all patients because of lack of available staff | Posted | Mean | Standard Deviation | ml/kg/min | Within 12 hours of life |
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| 3 |
| 24 |
| 2 |
| 24 |
| 2 |
| 24 |
| EG001 | 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. | 1 | 24 | 1 | 24 | 2 | 24 |
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| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |