Effect of PEEP on Lung Recruitment and Homogeneity Over Time in Moderate to Severe ARDS

NCT03140579 | Withdrawn

• 1 other identifier: 123456789
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS). It will do this by comparing the homogeneity of ventilation and recruitment prior to a patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.

Conditions

ARDS; Critical Illness; Ventilator-Induced Lung Injury

Keywords

recruitment; lung homogeneity; airway pressure release ventilation

Outcome Measures

Primary Outcomes (1)

• To compare lung homogeneity estimated with EIT upon commencing APRV (APRVpre) and after 30 - 60 - 120 min of APRV ventilation (APRV30, APRV60, APRV120) in patients with moderate to severe ARDS

  EIT will be measured at time APRVpre during a "low-flow maneuver" consisting of a brief switch to PC ventilation: with a flow of 4 L/min, airway pressure will be gradually increased up to 30 cmH20 in order to see how the lung changes elastically minimising resistance. EIT will also be measured after 30 min (time APRV30), 60 min (time APRV60), 120 min (time APRV120) since APRV has started.

  30, 60 and 120 mins

Secondary Outcomes (2)

• To assess recruitment at the beginning and after the end of APRV ventilation in patients with moderate-severe ARDS.

  2 hours

• To compare lung strain measured at APRVpre and after the end of APRV ventilation (APRVpost) in patients with moderate-severe ARDS

  2 hours

Interventions

APRV OTHER

Airway pressure release ventilation is a method of inverse ventilation, where high levels of positive end expiratory pressure are maintained to optimise oxygenation with brief releases of pressure to allow ventilation and release carbon dioxide. It is an approved and frequently used method of ventilation.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Patients admitted to ICU ventilated with moderate or severe ARDS, based on the Berlin definition of ARDS.

You may qualify if:

• Age ≥ 18 years and \< 80 years
• Weight \> 35 Kg and BMI \< 40
• Informed consent according to local regulations
• Hemoglobin ≥ 70 g/dl
• Haemodynamically stable \> 4 hours
• Moderate to severe ARDS (PaO2/FIO2 \< 26.6 kPa with positive end-expiratory pressure (PEEP) \> 5 cmH2O) as per Berlin definition of ARDS

You may not qualify if:

• Expected survival \< 72 hours
• Suspected pregnancy (negative pregnancy test required for women of child-bearing potential)
• Open abdomen
• Documented or suspected raised intracranial pressure
• Active air leak (pneumothorax, pneumomediastinum, subcutaneous emphysema)
• Morbid obesity BMI \> 40
• Recent \< 1 week cardiac or thoracic surgery
• Unstable thorax and sternum with paradoxical chest wall movement
• Severe Chronic Respiratory Disease (COPD) - GOLD 3 or 4 emphysema with bullae
• Severe smoking (\> 40 pack-year history)
• Liver Failure: Child-Pugh Class C
• Massive ascites
• Lung fibrosis
• Severe cardiac disease (one of the following): New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias
• Sickle cell disease

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Critical Illness; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Luigi Camporota

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: June 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)