Effects of End-inspiratory Pause on Ventilation

NCT06692634 | Not Yet Recruiting DMC

• 1 other identifier: O01102022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effect of reducing tidal volume and respiratory rate together with an end-inspiratory pause setting on ventilatory efficiency and the distribution of inspired gas within the lungs in ARDS patients. The study will use non-invasive monitoring of respiratory function with volumetric capnography and tomography by electrical impedance to evaluate the physiologic function. The expected results include a significant reduction of mechanical energy delivered by mechanical ventilation, improved ventilatory efficiency, and generate more homogenous ventilation with the end-inspiratory pause.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Ventilatory Failure; Hypercapnia; Alveolar Hypoventilation

Outcome Measures

Primary Outcomes (1)

• dead space reduction by 10%

  End inspiratory pause generates a 10% reduction of arterial carbon dioxide.

  After 60 minutes of applied the EIP setting

Study Arms (2)

Group 1

EXPERIMENTAL

Reduce tidal volume from 7 ml/kg to 5 ml/kg. Set end-inspiratory pause. respiratory rate reduction until 20% of the basal condition, together with a new increase in end-inspiratory pause.

Other: mechanical ventilation setting

Group 2

EXPERIMENTAL

Reduce tidal volume from 7 ml/kg to 5 ml/kg. Set end-inspiratory pause. respiratory rate reduction until 20% of the basal condition, and after that, will be set a new increase in end-inspiratory pause.

Other: mechanical ventilation setting

Interventions

mechanical ventilation setting OTHER

VT reduction, EIP setting, RR reduction, and a new EIP programing.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age with moderate and severe ARDS and up to 5 days of mechanical ventilation. Patients must be subjected to deep sedation and neuromuscular paralysis.

You may not qualify if:

• Patients with hemodynamic instability, acute heart failure, previous chronic respiratory disease, and variations in oesophageal temperature higher than 0.5 °C in the last 2 hours were excluded

Sponsors & Collaborators

• Clinica las Condes, Chile: lead

Study Sites (2)

Clínica Las Condes

Santiago, Santiago Metropolitan, 13114, Chile

Location

Martín Hernán Benites

Santiago, Santiago Metropolitan, 7550000, Chile

Location

Related Publications (4)

• Devaquet J, Jonson B, Niklason L, Si Larbi AG, Uttman L, Aboab J, Brochard L. Effects of inspiratory pause on CO2 elimination and arterial PCO2 in acute lung injury. J Appl Physiol (1985). 2008 Dec;105(6):1944-9. doi: 10.1152/japplphysiol.90682.2008. Epub 2008 Sep 18.

  PMID: 18801962 BACKGROUND

• Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.

  PMID: 27558174 BACKGROUND

• Uttman L, Jonson B. A prolonged postinspiratory pause enhances CO2 elimination by reducing airway dead space. Clin Physiol Funct Imaging. 2003 Sep;23(5):252-6. doi: 10.1046/j.1475-097x.2003.00498.x.

  PMID: 12950321 BACKGROUND

• Aboab J, Niklason L, Uttman L, Brochard L, Jonson B. Dead space and CO(2) elimination related to pattern of inspiratory gas delivery in ARDS patients. Crit Care. 2012 Dec 12;16(2):R39. doi: 10.1186/cc11232.

  PMID: 22390777 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypoventilation; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martín Benites, MD

  Clínica Las Condes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martín Benites, MD

CONTACT

+56 9 59226347; benitesmartinh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Step I: VT 7 ml/kg-PBW, with constant PEEP, RR, and insufflation time (0.6 sec), without adding an EIP. I:E ratio 1:2. Step II: VT 5 ml/kg-PBW keeping the other mechanical ventilation settings constant. Step III: EIP will be configured to achieve an I:E ratio of 1:1, keeping the other mechanical ventilation settings constant. Step IV: Patients will be randomized into two groups in a 1:1 ratio. Group 1: 20% reduction in RR together with a new setting in EIP until reach I:E equal 1, without modifying the other mechanical ventilation settings. Group 2: 20% reduction in RR without modifying the other mechanical ventilation settings. A modification of the I:E ratio will be generated concerning step III. After 60 minutes, a new EIP setting will be made until reaching an I:E ratio equal to 1. All steps will have a 60-minute long. Both arms will have the same programming of the mechanical ventilator at the end of the study.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)