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

Primary Purpose

Delivery Room Resuscitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
End tidal CO2 monitor
Sponsored by
Neil Finer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delivery Room Resuscitation focused on measuring ventilation, end tidal carbon dioxide, hypercapnia, hypocapnia, positive pressure ventilation, neonates, delivery room resuscitation

Eligibility Criteria

undefined - 15 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Monitored Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

End Tidal CO2 Levels
The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.
Duration of Ventilation
The number of days on the ventilator during the entire hospital course will be counted for this outcome.
Oxygen Use at 36 Weeks
This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.
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.
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
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.

Full Information

First Posted
June 21, 2011
Last Updated
December 4, 2019
Sponsor
Neil Finer
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1. Study Identification

Unique Protocol Identification Number
NCT01381068
Brief Title
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Official Title
Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (Actual)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neil Finer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery Room Resuscitation
Keywords
ventilation, end tidal carbon dioxide, hypercapnia, hypocapnia, positive pressure ventilation, neonates, delivery room resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitored Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
End tidal CO2 monitor
Other Intervention Name(s)
NICO 2 Respiratory Profile Monitor (Respironics, Inc.)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PCO2 Level Outside of Desired Range (40-60 mmHg)
Description
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
Secondary Outcome Measure Information:
Title
End Tidal CO2 Levels
Description
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.
Title
Duration of Ventilation
Description
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
Title
Oxygen Use at 36 Weeks
Description
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
Title
Incidence of Pneumothorax/Airleak
Description
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
Title
Number of Patients Ventilated on NICU Admission
Description
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
Title
Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow
Description
An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.
Time Frame
Within 12 hours of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
15 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina A Leone, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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

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