Actively Recruiting

Age: 18Years +
All Genders
ID04484727

Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs

Led by Göteborg University · Updated on 2025-03-17

200

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

G

Göteborg University

Lead Sponsor

S

Sahlgrenska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups: ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure (PEEP) up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients above 18 years
  • ASA physical status classification 1 to 3
  • Planned or acute ventilator treatment in intensive care or operating room
Not Eligible

You will not qualify if you...

  • Patients under 18 years
  • ASA physical status classification 4 and above
  • Severe COPD, emphysema, or heart failure
  • PEEP higher than 16 cmH2O and/or FiO2 above 80%
  • Elevated intracranial pressure
  • Known or suspected pneumothorax that is untreated
  • Coagulation disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at preoperative assessment or surrogate consent process in ICU

Monitoring

Duration - Up to 1 year, through study completion

Participants are monitored with non-invasive lung elastance measurements using the PEEP-step method during mechanical ventilation in surgery or intensive care.

Measurements during mechanical ventilation including initial two-step PEEP procedure and repeated one-step PEEP procedures during clinical events

Long-term Monitoring

Duration - Up to 1 year, through study completion

Participants are followed for outcomes such as lung elastance changes, duration of ventilator treatment, and complications after respiratory treatment.

Clinical assessments and data collection during the entire follow-up period

Trial Site Locations

Total: 1 location

1

Sophie Lindgren

Gothenburg, Västra Götaland County, Sweden, 41345

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Research Team

S

Sophie Lindgren, Assoc prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Transpulmonary and pleural pressure in a respiratory system model with an elastic recoiling lung and an expanding chest wall.

Per Persson, Stefan Lundin, Ola Stenqvist

https://pubmed.ncbi.nlm.nih.gov/27645151