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

Delivery Room Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381068
• Other study ID #: 090780
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Delivery Room Resuscitation
• Hypercapnia

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Neil Finer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Admission to NICU, approximately 1 hour of life
Secondary	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.
Secondary	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
Secondary	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
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.	Hospital course, approximately 2-3 months
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	On NICU admission, approximately 15 minutes of life
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.	Within 12 hours of life