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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGöteborg University

About this trial

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directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn.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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients above18 years

ASA 1-3

Planned/acute ventilator treatment in ICU or OR

Disqualifiers

Patients under 18 years

ASA 4 and above

severe COPD/emphysema/heart failure

PEEP>16 and/or FiO2 >80%

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PEEP-step method

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ICU-patients in ventilator treatment1 intervention
Group B: Surgery-patients during general anaesthesia1 intervention

Trial outcomes

Primary outcomes

1

Lung-elastance, changes

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

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Hours/Days of ventilator treatment

Registration of Hours/Days of ventilator treatment

Time frame
Through study completion, an average of 1 year
2

Postoperative complications, ICU-complications

Registration of the most common postoperative and ICU-complications

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Göteborg University

Lead sponsor

Sahlgrenska University Hospital

Collaborator