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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435613
• Other study ID #: S022018
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2021
• Source: Clinica las Condes, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Protective mechanical ventilation strategies are currently the cornerstone of treatment for patients undergoing mechanical ventilatory support. Among them, we can mention the reduction in tidal volume, the reduction in driving pressure, the PEEP setting, and the respiratory rate reduction. All of these strategies are aimed at preventing ventilator-induced lung injury. Few clinical studies have evaluated the effects of protective mechanical ventilation strategies on dead-space. This study was designed to evaluate dead space and alveolar ventilation with a sequence of protective ventilatory strategies, keeping PEEP levels constant. The ventilatory strategy was developed to reduce tidal volume, set an end-inspiratory pause, and reduce the frequencies of lung tissue impact. Baseline: All the patients kept the variables under study constant for 60 minutes. Each of the participants was studied for a period of 150 minutes. PEEP programming was set with transpulmonary end-expiratory pressures to maintain between 0 and 5 cmH2O and was remained constant throughout the study. Protocol design: Baseline: Vt 7 ml/kg/PBW Phase I: Vt 6 ml/kg/PBW. Phase II: Vt 5 ml/kg/PBW. Phase III: end-inspiratory pause prolongation until achieving I:E ratio equal to 1, maintaining a constant Vt level (5 ml/kg/PBW) Phase IV: Respiratory rate reduction by 20% of basal conditions, maintaining constant VT level (5 ml/kg/PBW). After 30 minutes of continuous monitoring, minute ventilation, mechanical power, variables obtained by volumetric capnography, and arterial blood gases were recorded in each study phase. This study will be performed in the Intensive Care Unit of a University Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2020
• Est. primary completion date: August 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• ARDS
• Volumetric Capnography

Intervention

Other:
• protective mechanical ventilation strategies
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

Locations

Country	Name	City	State
Chile	Clínica Las Condes	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Clinica las Condes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (7)

Aguirre-Bermeo H, Morán 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. — View Citation

Aström 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. Epub 2007 Sep 1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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