Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients

NCT04435613 | Completed DMC

• 1 other identifier: S022018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied

Conditions

ARDS; Volumetric Capnography

Keywords

dead space, end-inspiratory pause, respiratory rate, ARDS

Outcome Measures

Primary Outcomes (1)

• To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome

  After the systematic reduction of the tidal volume, end-inspiratory pause prolongation, and the reduction of the respiratory rate, the optimisation of the dead space and the alveolar ventilation could be generated.

  150 minutes

Study Arms (1)

protective mechanical ventilation

OTHER

Ten patients with moderate to severe ARDS were subjected to a nearly ultra-protective ventilation strategy generating a reduction in minute ventilation (Tidal volume of 5 ml/kg of predicted body weight together with a 20% reduction in respiratory rate). In addition to end-inspiratory pause, prolongation was set to avoid hypercapnia. Protocol phases: Baseline conditions: Tidal volume of 7 ml/kg. I: Tidal volume of 6 ml/kg. II: Tidal volume of 5 ml/kg. III: Increase end-inspiratory pause until achieving an I:E ratio equal to 1. IV: Respiratory rate reduction until 20% of the basal condition keeping constant I:E ratio equal to 1

Other: protective mechanical ventilation strategies

Interventions

protective mechanical ventilation strategies OTHER

1\. Reduce tidal volume from 7 ml/kg to 5 ml/kg. 2 Set end-inspiratory pausa. 3 respiratory rate reduction until 20% of the basal condition

protective mechanical ventilation

Eligibility Criteria

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

You may qualify if:

• Age older than 18 years
• The requirement of invasive mechanical ventilation for more than 4 hours and less than 72 hours
• Severe hypoxemia (PAFI \< 200) secondary to ARDS

You may not qualify if:

• Heart failure stage IV
• Chronic obstructive pulmonary disease (COPD) on home oxygen
• Bronchopulmonary fistula
• Hypovolemic Shock with active hemorrhage
• Gastrointestinal bleeding
• Oesophageal Varices
• Nasopharynx surgery, recent oesophageal or gastric surgery
• Massive Pulmonary Thromboembolism
• Catastrophic respiratory failure requiring urgent extracorporeal life support
• Respiratory acidosis. Hydrogen potential (pH) is less than 7.20 and PaCO2 higher than 60 mmHg at baseline.

Sponsors & Collaborators

• Clinica las Condes, Chile: lead

Study Sites (1)

Clínica Las Condes

Santiago, Santiago Metropolitan, 13114, Chile

Location

Related Publications (7)

• Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

  PMID: 27620287 BACKGROUND

• Tusman G, Sipmann FS, Borges JB, Hedenstierna G, Bohm SH. Validation of Bohr dead space measured by volumetric capnography. Intensive Care Med. 2011 May;37(5):870-4. doi: 10.1007/s00134-011-2164-x. Epub 2011 Feb 26.

  PMID: 21359609 BACKGROUND

• Tusman G, Gogniat E, Bohm SH, Scandurra A, Suarez-Sipmann F, Torroba A, Casella F, Giannasi S, Roman ES. Reference values for volumetric capnography-derived non-invasive parameters in healthy individuals. J Clin Monit Comput. 2013 Jun;27(3):281-8. doi: 10.1007/s10877-013-9433-x. Epub 2013 Feb 7.

  PMID: 23389294 BACKGROUND

• Lellouche F, Delorme M, Brochard L. Impact of Respiratory Rate and Dead Space in the Current Era of Lung Protective Mechanical Ventilation. Chest. 2020 Jul;158(1):45-47. doi: 10.1016/j.chest.2020.02.033. Epub 2020 Jul 2. No abstract available.

  PMID: 32654726 BACKGROUND

• Astrom E, Uttman L, Niklason L, Aboab J, Brochard L, Jonson B. Pattern of inspiratory gas delivery affects CO2 elimination in health and after acute lung injury. Intensive Care Med. 2008 Feb;34(2):377-84. doi: 10.1007/s00134-007-0840-7. Epub 2007 Sep 1.

  PMID: 17763841 BACKGROUND

• 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

Study Officials

• Martín Benites Albanese, Physician

  Critical Care Department, Clínica Las Condes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Martín Hernán Benites Albanese

Model Details: A quasi-experimental, non-randomized study

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: September 4, 2019
• Primary Completion: August 29, 2020
• Study Completion: August 30, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

CL (1)