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

Critical Illness Clinical Trial

— APRV  

Official title:

Estimation of Long Term PEEP Effect on Lung Homogeneity and Recruitment Using APRV Ventilation:Measurement of End Expiratory Lung Volume With Nitrogen Wash-out/wash-in Technique and End Expiratory Lung Impedance With EIT at Different Times.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03140579
• Other study ID #: 123456789
• Status: Withdrawn
• Start date: June 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Ventilator-induced lung injury (VILI) is a well-recognised problem of ventilation in patients with ARDS, and is currently treated with lung-protective ventilation, which limits tidal volumes and airway pressures by applying higher levels of positive-end expiratory pressure (PEEP). However, it is not known whether higher levels of PEEP increases recruitment and homogeneity of ventilation within the lungs.

APRV is a mode of inverse ventilation, where high levels of PEEP are maintained with brief releases of pressure, and has been proposed as an appropriate method of ventilation in patients with ARDS.

This study will assess homogeneity of ventilation and recruitment in 15 patients before APRV is started, and 30, 60 and 120 mins after commencing APRV. It will do this using Electrical Impedance Tomography (EIT), nitrogen wash in/wash out technique, and lung strain.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• ARDS
• Critical Illness
• Lung Injury
• Ventilator-Induced Lung Injury

Intervention

Other:
• APRV
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.

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess recruitment at the beginning and after the end of APRV ventilation in patients with moderate-severe ARDS.	To assess recruitment measuring change in end expiratory lung impedance (EELI) with EIT technique, and EELV with nitrogen wash-out/wash-in technique.	2 hours
Secondary	To compare lung strain measured at APRVpre and after the end of APRV ventilation (APRVpost) in patients with moderate-severe ARDS	Strain will be calculated at time APRVpre using the strain formula (TV/EELV)	2 hours