Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants

NCT02528851 | Unknown DMC

• 1 other identifier: CO-PAP
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the cardiovascular and respiratory effects of "higher" versus "equivalent" CPAP pressures post-extubation from high endotracheal airway pressures (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure (MAP) \[if on high frequency ventilation\] or positive end-expiratory pressure (PEEP) \[if on conventional ventilation\] at time of extubation. Participants will be randomized to "higher" CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We hypothesize that "higher" CPAP levels, when compared to "equivalent" CPAP levels, do not adversely impact the cardiorespiratory status when a patient is extubated from high EAP.

Conditions

Preterm Infant

Keywords

CPAP; preterm; cardiac output

Outcome Measures

Primary Outcomes (1)

• Left ventricular output

  We will use the formula LVO = \[LV Outflow Tract (LVOT) area x Quantity of blood across LVOT x heart rate\]/body weight (ml/kg/min). The details of measurement of each component of the equation are as follows: * LVOT area = π (LV outflow tract diameter/2)2. LV outflow tract diameter will be measured in the parasternal long axis in late systole immediately distal to the valve orifice using the leading edge technique. * Quantity of blood across the LVOT: To be measured using the VTI (velocity time integral) from pulsed Doppler echocardiography from the modified apical view (5-chamber view)

  One hour after each intervention

Secondary Outcomes (7)

• Heart rate

  One hour after each intervention

• Blood pressure

  One hour after each intervention

• abdominal wall girth

  One hour after each intervention

• Silverman-Andersen respiratory score

  One hour after each intervention

• Lung compliance

  Pre-extubation measurement in all recruited infants

Study Arms (2)

Higher CPAP

EXPERIMENTAL

Infants extubated to CPAP level 2cm H2O higher than extubation EAP

Procedure: Extubation from endotracheal mechanical ventilation to CPAP

Equivalent CPAP

ACTIVE COMPARATOR

Infants extubated to CPAP equivalent to extubation EAP

Procedure: Extubation from endotracheal mechanical ventilation to CPAP

Interventions

Extubation from endotracheal mechanical ventilation to CPAP PROCEDURE

Following randomization, the infants will be extubated to the "higher" CPAP group (CPAP level 2cm H2O higher than extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) based on their allocation.

Equivalent CPAP; Higher CPAP

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All preterm infants less than 37 weeks of gestation who are mechanically ventilated with Endotracheal Airway Pressure (EAP) ≥ 8 cm H2O at time of extubation as per the medical team.
• Note: The decision to extubate a subject, and EAP at time of extubation, will solely be that of the medical team, and is in no way dictated by the study protocol.

You may not qualify if:

• Infants on EMV with EAP\> 11 cmH2O at the time of extubation
• Congenital or acquired abnormality of upper airway
• Major gastrointestinal disorder or complication
• Suspected/proven chromosomal/genetic abnormality
• Suspected/confirmed sepsis being treated at time of extubation
• Unresolved hemodynamically significant patent ductus arteriosus (with or without inotropic support) at time of extubation
• Congenital structural heart diseases
• Infants requiring vasopressor and/or inotropic support at time of extubation
• Persistent pulmonary hypertension requiring treatment with vasopressors/inhaled nitric oxide/sildenafil at time of extubation

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Souvik Mitra, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Souvik Mitra, MD

CONTACT

19059621091; mitras@mcmaster.ca

Amit Mukerji, MD

CONTACT

mukerji@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 19, 2015

Record last verified: 2015-08