Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR) - Full Text View

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:

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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

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 May 19, 2013