Measuring Lung Pressures in Critically Ill Children Who Are on Mechanical Ventilation

NCT02354365 | Unknown DMC

• 1 other identifier: CCI-13-00370
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Typically doctors adjust the settings on the ventilator to ensure that children receive enough help to decrease the work they perform to breathe, receive enough oxygen through the machine to pass into the blood and to the organs, and remove acid that builds up in the blood. However, sometimes the settings we choose can result in damage to the lungs. We are trying to find a better way to determine the best ventilator settings, which can minimize potential damage to the lungs, and still provide children with enough support to decrease the work they have to do to breathe. We believe we can personalize these choices for each child by looking at the pressure that is generated in the chest while children breathe with the ventilator. This is accomplished by using a small tube which goes through the nose and into the esophagus or stomach, which is hooked up to a computer or the ventilator to monitor pressure. This same tube can then also be used to monitor how much work children need to do to breathe as we are turning down the ventilator in preparation to remove the breathing tube.

Conditions

Transpulmonary Pressure; Pressure.Rate Product; Guide to Mechanical Ventilator Management; Extubation Readiness

Keywords

PEEP adjustment; Tidal Volume; Driving Pressure; Compliance

Outcome Measures

Primary Outcomes (1)

• Transpulmonary pressure

  Effect of cardiac index of increasing PEEP guided by transpulmonary pressure at PEEP.

  Two years

Secondary Outcomes (1)

• Pressure rate product (PRP)

  Two years

Study Arms (3)

Normal lungs

Mechanically ventilated patients without pulmonary parenchymal disease or lower airway disease as measured by flow volume loops consistent with expiratory flow obstruction (e.g. seizures, apnea, upper airway obstruction).

Device: Transpulmonary Pressure measurement

Acute Hypoxic Respiratory Failure

Mechanically ventilated patients with two consecutive Saturation to FiO2 (SF) ratio \< 265 or PaO2 to FiO2 (PF) ratio \< 300 (e.g. pneumonia, ARDS).

Device: Transpulmonary Pressure measurement

Obstructive airway disease

Mechanically ventilated patients with flow volume loops consistent with expiratory flow obstruction (e.g. asthma, bronchiolitis).

Device: Transpulmonary Pressure measurement

Interventions

Transpulmonary Pressure measurement DEVICE

Transpulmonary pressure measurements are done by placing a catheter (often combined with a feeding tube) into the esophagus of a patient. Intermittently, the esophageal pressure is measured by inflating a small balloon on this catheter. The resulting esophageal pressure is accepted as representing the pleural pressure. The difference between this pressure and the airway pressure is the transpulmonary pressure and PEEP is raised or lowered to make this value zero so that the forces distending the alveoli are just balanced with the natural elasticity of the lung which wants to collapse the alveoli.

Acute Hypoxic Respiratory Failure; Normal lungs; Obstructive airway disease

Eligibility Criteria

• Age: 1 Week - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Any patient weighing \>2 kg between the ages of \> 37 weeks corrected gestational age and \<18 years who is intubated and mechanically ventilated in the pediatric intensive care unit at Children's Hospital Los Angeles will be eligible for the study.

You may qualify if:

• We seek to group patients into 3 potential cohorts:
• Normal Lungs (maximum 30 patients): Mechanically ventilated patients without pulmonary parenchymal disease or lower airway disease as measured by flow volume loops consistent with expiratory flow obstruction (e.g. seizures, apnea, upper airway obstruction).
• AHRF (maximum 15 patients): Mechanically ventilated patients with two consecutive Saturation to FiO2 (SF) ratio \< 265 or PaO2 to FiO2 (PF) ratio \< 300 (e.g. pneumonia, ARDS).
• Obstructive airway disease (15 patients): Mechanically ventilated patients with flow volume loops consistent with expiratory flow obstruction (e.g. asthma, bronchiolitis)

You may not qualify if:

• Patients with a corrected gestational age of \< 37 weeks or above 18 years of age. Patients with esophageal pathology or inability to utilize an esophageal probe due to anatomy, those on a high frequency oscillator or jet ventilator and those with uncorrected or persistent cyanotic congenital heart diseases will be excluded. Also, patients with an endotracheal tube leak of more than 18% or inability to measure volume, pressure or flow at the endotracheal tube will be excluded from the study

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (4)

• Ingaramo OA, Ngo T, Khemani RG, Newth CJ. Impact of positive end-expiratory pressure on cardiac index measured by ultrasound cardiac output monitor*. Pediatr Crit Care Med. 2014 Jan;15(1):15-20. doi: 10.1097/PCC.0b013e3182976251.

  PMID: 24389709 BACKGROUND

• Ross PA, Khemani RG, Rubin SS, Bhalla AK, Newth CJ. Elevated positive end-expiratory pressure decreases cardiac index in a rhesus monkey model. Front Pediatr. 2014 Dec 3;2:134. doi: 10.3389/fped.2014.00134. eCollection 2014.

  PMID: 25520944 BACKGROUND

• Hotz JC, Sodetani CT, Van Steenbergen J, Khemani RG, Deakers TW, Newth CJ. Measurements Obtained From Esophageal Balloon Catheters Are Affected by the Esophageal Balloon Filling Volume in Children With ARDS. Respir Care. 2018 Feb;63(2):177-186. doi: 10.4187/respcare.05685. Epub 2017 Oct 31.

  PMID: 29089460 BACKGROUND

• Virk MK, Hotz JC, Wong W, Khemani RG, Newth CJL, Ross PA. Minimal Change in Cardiac Index With Increasing PEEP in Pediatric Acute Respiratory Distress Syndrome. Front Pediatr. 2019 Jan 29;7:9. doi: 10.3389/fped.2019.00009. eCollection 2019.

  PMID: 30761278 RESULT

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christopher Newth, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Critical Care Medicine, Attending Physician

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: February 1, 2014
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)