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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01381068
First received: June 21, 2011
Last updated: July 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Delivery Room Resuscitation
Device: End tidal CO2 monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • PCO2 level inside or outside of desired range (40-60 mmHg) [ Time Frame: Admission to NICU, approximately 1 hour of life ] [ Designated as safety issue: No ]
    This outcome will be obtained from the first available blood gas after admission to the NICU.


Secondary Outcome Measures:
  • End tidal CO2 levels [ Time Frame: At the conclusion of resuscitation, approximately 15 minutes of life. ] [ Designated as safety issue: No ]
    The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.

  • Duration of ventilation [ Time Frame: Duration of the hospital course, approximately 2-3 months ] [ Designated as safety issue: No ]
    The number of days on the ventilator during the entire hospital course will be counted for this outcome.

  • Oxygen use at 36 weeks [ Time Frame: Hospital course, approximately 2-3 months ] [ Designated as safety issue: No ]
    This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.

  • Incidence of pneumothorax/airleak [ Time Frame: Hospital course, approximately 2-3 months ] [ Designated as safety issue: No ]
    This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.

  • Incidence of Severe IVH/PVL [ Time Frame: Hospital Course, approximately 2-3 months ] [ Designated as safety issue: No ]
    This outcome will be counted as yes if the highest grade on any ultrasound done during hospitalization was Grade 3-4 or PVL was present on any ultrasound during the hospitalization.

  • Ventilator Settings on NICU admission [ Time Frame: On NICU admission, approximately 15 minutes of life ] [ Designated as safety issue: No ]
    The ventilator settings will be recorded at the time of NICU admission directly after the DR resuscitation.

  • Systemic blood flow [ Time Frame: Within 10 hours of life ] [ Designated as safety issue: No ]
    An echocardiogram performed within the first 10 hours of life will evaluate the right ventricular output (RVO), supervior vena cava (SVC) flow, patent ductus arteriosus and patent foramen ovale shunting. The SVC flow and RVO will be compared between groups.


Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
Other Name: NICO 2 Respiratory Profile Monitor (Respironics, Inc.)
Placebo Comparator: 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.
Device: 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.
Other Name: NICO 2 Respiratory Profile Monitor (Respironics, Inc.)

  Eligibility

Ages Eligible for Study:   up to 15 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381068

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Tina A Leone, MD UCSD
  More Information

No publications provided

Responsible Party: Tina Leone, MD/Assistant Clinical Professor of Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01381068     History of Changes
Other Study ID Numbers: 090780
Study First Received: June 21, 2011
Last Updated: July 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
ventilation
end tidal carbon dioxide
hypercapnia
hypocapnia
positive pressure ventilation
neonates
delivery room resuscitation

ClinicalTrials.gov processed this record on September 22, 2014