"Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"

NCT04484727 | Recruiting

• 1 other identifier: ALF-75130-5027
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Little is known about how lung mechanics are affected during the very early phase after starting mechanical ventilation. Since the conventional method of measuring esophageal pressure is complicated, hard to interpret and expensive, there are no studies on lung mechanics on intensive care patients directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn. Published studies have collected data using the standard methods from day 1 to 3 of ventilator treatment for respiratory system mechanics, i.e. the combined mechanics of lung and chest wall. Consequently, information on lung mechanical properties during the first critical hours of ventilator treatment is missing and individualization of ventilator care done on the basis of respiratory system mechanics, which are not representative of lung mechanics on an individual patient basis. We have developed a PEEP-step method based on a change of PEEP up and down in one or two steps, where the change in end-expiratory lung volume ΔEELV) is determined and lung compliance calculated as ΔEELV divided by ΔPEEP (CL = ΔEELV/ΔPEEP). This simple non-invasive method for separating lung and chest wall mechanics provides an opportunity to enhance the knowledge of lung compliance and the transpulmonary pressure. After the two-PEEP-step procedure, the PEEP level where transpulmonary driving pressure is lowest can be calculated for any chosen tidal volume. The aim of the present study in the ICU is to survey lung mechanics from start of mechanical ventilation until extubation and to determine PEEP level with lowest (least injurious) transpulmonary driving pressure during ventilator treatment. The aim of the study during anesthesia in the OR, is to survey lung mechanics in lung healthy and identify patients with lung conditions before anesthesia, which may have an increased risk of postoperative complications.

Conditions

Ventilator-Induced Lung Injury; Ventilatory Failure; Ventilator Lung; Ventilation Therapy; Complications; Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Lung-elastance, changes

  Data-collection after intubation, during interventions such as suction, inhalation, posture changes

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Hours/Days of ventilator treatment

  Through study completion, an average of 1 year

• Postoperative complications, ICU-complications

  Through study completion, an average of 1 year

Study Arms (2)

ICU-patients in ventilator treatment

Directly after intubation and start of mechanical ventilation, a two-PEEP-step up and down procedure with steps of 5-7 cmH2O each is performed and data on airway pressure and tidal volume changes collected. The data is transferred into a dedicated software for calculation of ΔEELV by cumulative difference in expiratory tidal volume before and during PEEP inflation. Consequently, the lung P/V curve from baseline clinical PEEP to end-inspiration of the highest PEEP level. The PEEP level where clinically used tidal volume has the lowest transpulmonary driving pressure is calculated. A one-PEEP-step procedure with a step of 5-7 cmH2O is performed when clinical events such as disconnection of the breathing circuit, posture changes, suctioning, inhalation, CO2 insufflation etc. is performed, and repeated during the whole period of ventilator treatment.

Other: PEEP-step method

Surgery-patients during general anaesthesia

Directly after intubation and start of mechanical ventilation, a two-PEEP-step up and down procedure with steps of 5-7 cmH2O each, is performed in the same way as described for ICU patients. Data of airway pressure and volumes are transferred into a dedicated software for calculation of ΔEELV by cumulative difference in expiratory tidal volume before and during PEEP inflation. Consequently, the lung P/V curve from baseline clinical PEEP to end-inspiration of the highest PEEP level. The PEEP level where clinically used tidal volume has the lowest transpulmonary driving pressure is calculated. A one-PEEP-step procedure with a step of 5-7 cmH2O is performed when clinical events such as disconnection of the breathing circuit, posture changes or suctioning is performed, and before and after implementation of pneumoperitoneum.

Other: PEEP-step method

Interventions

PEEP-step method OTHER

By changing PEEP in one or two steps up and down, transpulmonary pressure and the lung P/V curve can be determined using a dedicated software collecting data on tidal-volume changes and pressure changes during the PEEP-changes from the standard monitoring equipment or ventilator.

ICU-patients in ventilator treatment; Surgery-patients during general anaesthesia

Eligibility Criteria

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

Study Population

ICU-patients or patients in surgery recieving invasive mechancial ventilation.

You may qualify if:

• Patients above18 years
• ASA 1-3
• Planned/acute ventilator treatment in ICU or OR

You may not qualify if:

• Patients under 18 years
• ASA 4 and above
• severe COPD/emphysema/heart failure
• PEEP\>16 and/or FiO2 \>80%
• elevated intracranial pressure
• defect coagulation
• non-treated known or suspected pneumothorax

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sophie Lindgren

Gothenburg, Västra Götaland County, 41345, Sweden

RECRUITING

Related Publications (6)

• Lundin S, Grivans C, Stenqvist O. Transpulmonary pressure and lung elastance can be estimated by a PEEP-step manoeuvre. Acta Anaesthesiol Scand. 2015 Feb;59(2):185-96. doi: 10.1111/aas.12442. Epub 2014 Dec 2.

  PMID: 25443094 BACKGROUND

• Stenqvist O, Grivans C, Andersson B, Lundin S. Lung elastance and transpulmonary pressure can be determined without using oesophageal pressure measurements. Acta Anaesthesiol Scand. 2012 Jul;56(6):738-47. doi: 10.1111/j.1399-6576.2012.02696.x. Epub 2012 Apr 23.

  PMID: 22524531 BACKGROUND

• Persson P, Lundin S, Stenqvist O. Transpulmonary and pleural pressure in a respiratory system model with an elastic recoiling lung and an expanding chest wall. Intensive Care Med Exp. 2016 Dec;4(1):26. doi: 10.1186/s40635-016-0103-4. Epub 2016 Sep 20.

  PMID: 27645151 BACKGROUND

• Persson P, Stenqvist O, Lundin S. Evaluation of lung and chest wall mechanics during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Apr;120(4):860-867. doi: 10.1016/j.bja.2017.11.076. Epub 2017 Dec 1.

  PMID: 29576127 BACKGROUND

• Stenqvist O, Persson P, Stahl CA, Lundin S. Monitoring transpulmonary pressure during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Dec;121(6):1373-1375. doi: 10.1016/j.bja.2018.08.018. Epub 2018 Oct 9. No abstract available.

  PMID: 30442269 BACKGROUND

• Stenqvist O, Persson P, Lundin S. Can we estimate transpulmonary pressure without an esophageal balloon?-yes. Ann Transl Med. 2018 Oct;6(19):392. doi: 10.21037/atm.2018.06.05.

  PMID: 30460266 BACKGROUND

Related Links

• Grivans C., Transpulmonary pressure during mechanical ventilation. Doctoral thesis. ISBN 978-91-628-8832-9.
• Persson P. Lung and chest wall properties during mechanical ventilation. Doctoral thesis. ISBN 978-91-7833-224-3

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Hypoventilation; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiratory Insufficiency; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Bengt Nellgård, Prof

  Sahlgrenska Academy

  STUDY CHAIR

Central Study Contacts

Sophie Lindgren, Assoc prof

CONTACT

+46313421000; sophie.lindgren@vgregion.se

Study Design

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

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 24, 2020
• Study Start: May 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)