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

Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?

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.

Study Overview

• Status: Completed
• Conditions: Delivery Room Resuscitation
• Intervention / Treatment: Device: End tidal CO2 monitor

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: NICO 2 Respiratory Profile Monitor (Respironics, Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Neil Finer
• Investigators: Principal Investigator: Tina A Leone, MD, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: ventilation; neonates; hypercapnia; hypocapnia; end tidal carbon dioxide; positive pressure ventilation; delivery room resuscitation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: 090780