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Pulmonary AtelectasisNCT03009331

Descriptive and Comparative Study of Respiratory Function in the Postoperative Cardiac Surgery Patient

A study testing Lungrecruitment manoeuver in prone position. and Lungrecruitment manoeuver in supine position. in people with Pulmonary Atelectasis, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study comprises two different objectives. Longitudinal description of postoperative pulmonary dysfunction in the cardiothoracic surgery patient, and the comparison of two different lungrecruitment strategies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Atelectasis
What is being tested?
Lungrecruitment manoeuver in prone position. and Lungrecruitment manoeuver in supine position.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSweden
Study dates
25 Jul 2017to 25 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Scheduled cardiac surgery (CABG or valve surgery)
  • Cardiopulmonary bypass

Who cannot join

  • Diagnose of obstructive or restrictive lung disease
  • Medical therapy with bronchodilators
  • Smoking or former smoking > 5 years
  • Obesity (BMI > 30)
  • Perioperative FiO2 >60% or PEEP >12
  • Haemodynmic instability, use of inotropes (low dose vasopressors accepted)
Show all 9Show fewer
  • Postop clinically significant bleeding (>100 ml/h, reoperation)
  • Postoperative haemothorax or large pleural effusion detected with ultrasonography
  • Postoperative clinically significant pneumothorax or large chestdrain airleak

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Department of cardiothoracic anaesthesia, Sahlgrenska University Hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

The study comprises two different objectives. Longitudinal description of postoperative pulmonary dysfunction in the cardiothoracic surgery patient, and the comparison of two different lungrecruitment strategies.

Read the detailed description

Introduction:

Atelectasis and consolidation of lung tissue is a well recognized clinical scenario following anaesthesia, musclerelaxation and mechanical ventilation. In cardiac surgery during cardiopulmonary bypass (CPB), the lungs are collapsed to a degree depending on surgical opening of the pleura, time on bypass, and gasmixture on termination of ventilation. Recruitment of the lungs on commencement of mechanical ventilation after CPB generally must be repeated before extubation. There are several different approaches to Recruitment Manoeuvers (RM). Increasing pressures in the ventilator (peak-pressures and PEEP), increasing tidal volumes and inspiratory hold are facilities offered by the ventilator. Different body positions by interaction of the abdomen and thorax through the diaphragm, and the action of gravity on the lungs and adjoining organs, are other principles. The contribution of spontaneous ventilatory efforts also play a major roll.

Study rationale:

The study comprises two different objectives. Longitudinal description of postoperative pulmonary dysfunction in the cardiothoracic surgery patient, and the comparison of two different lungrecruitment strategies.

All patients undergoing cardiothoracic surgery develops some degree of postoperative pulmonary dysfunction (PPD), including hypoxemia, increased work of breathing, shallow respiration and ineffective cough. Respiratory symptoms of larger clinical significance are better investigated, known as postoperative pulmonary complications (PPC), including pleural effusion, atelectasis, pneumonia and ARDS. Pathophysiology is complex and multifactorial, and there is a continuum between PPD and PPC that has not yet been well explored. A large proportion of patients readmitted to CICU present respiratory failure, significantly accounting for morbidity, mortality, and costs.

Regarding lungrecruitment, supine position is compared to modified prone position with similar ventilator settings. Initial measurements preoperatively in the awake patient, then during sedation and ventilator treatment, followed up by measurements before discharge from the surgical ward on postoperative day 4-5.

Effect of RM is evaluated from ventilator measurement of compliance (C), arterial oxygenation and P/F-ratio from the arterial blood gas (ABG), and electrical impedance tomography (EIT). EIT measures the impedance of a thoracic sagittal section by emitting and sampling electrical currents between 16 electrodes fixed on a submamillar belt. Radiology report from routine chest X-ray and ultrasonography of the lungs and pleura will be added.

Should RM in prone position prove to be more efficient, postoperative complications in terms of respiratory failure and pneumonia could be reduced, facilitating postoperative recovery and shortening convalescens. This would justify the increased burden of care in the cardiac ICU.

Study objectives:

The study aims to compare lung recruitment in two different body positions, supine (elevated 30 degrees) to left modified prone position (left side up, 120 degrees). Parameters investigated are global and regional pulmonary impedance (EIT), lungcompliance, and arterial oxygenation. Chest X-ray and lung ultrasound will be performed for additional analyses.

A descriptive longitudinal study of the 20 patients lungrecruited in supine position will also be performed.

Study design:

Prospective, randomized clinical trial. Two groups with 20 cardiac surgery patients in each.

Study procedure:

Protocol

Day -1:

1 day preop. EIT measurement in supine (30 degrees elevated) and modified left prone position (left side up, 120 degrees). Two measurements of each 2 min duration in both positions. ABG is performed after breathing through a Venturi-mask delivering FiO2 0.5 for 10 minutes. Randomization to either of the two groups.

Day 0:

Day of surgery. Standard periop care in coherence with department routines. Preoxygenation using FiO2 1.0 during induction of anaesthesia, and before commencing cardiopulmonary bypass (CPB). Inhalational anaesthetics during surgical preparation, and again after weaning from CPB. Apnoea without PEEP or intermittent ventilation during CPB. Before weaning from CPB manual lung recruitment with the APL-valve set to 30 cm H2O, and visual guidance of the lungparenchyma or pleura. After chest closure, FiO2 is set to 0.5, volume controlled ventilation 4-6 ml/Kg titrated according to pCO2, and PEEP is set to 5 cm H2O. Patient ventilation circuit will be broken twice in conjugation with the use of a transport ventilator device before arrival in the CICU. Ventilator settings in the CICU is pressure-regulated volume-controlled ventilation (VKTS), tidal volumes of 4-6 ml/Kg titrated according to pCO2, respiratory frequency of 14/min, and PEEP 8 cm H2O.

Recruitment maneuver (RM) is performed within 10 min on arrival in the CICU. Patient must be stabile in hemodynamic parameters, including volume status. PEEP is set to 20 cm H2O, pressure controlled ventilation with peak pressure 40 cm H2O for 30 s (5 inspirations), thereafter PEEP-trial starting from 15 cm H2O for optimal PEEP using the "Open Lung Tool" (Maquet Flow-i software). During the PEEP-trial, VKTS for tidal volumes of 6 ml/Kg is used.

Supine position group: RM in supine position. EIT, ABG and lung compliance measurements in supine position before RM (30 degrees elevation), then immediately and 30 min after RM, and again 30 minutes after extubation. FiO2 0.5 at all ABG measuring points.

Modified prone position group: RM in modified prone position (120 degrees, left side up). EIT, ABG and lung compliance measurements in supine position before RM (30 degrees elevation), and then immediately after RM when turned back to supine position (30 degrees elevation), and 30 minutes after RM. Finally, measurements 30 minutes after extubation. FiO2 0.5 at all ABG measuring points.

Day 4-5:

Supine and prone position groups: EIT in supine position (30 degrees elevation) and ABG repeated at day 4-5 postop. ABG is performed after breathing through a Venturi-mask delivering FiO2 0.5 for 10 minutes. Ultrasonography of the pleurae. Chest-X-ray performed routinely on the day after chest-drain removal.

Being tested
Lungrecruitment manoeuver in prone position., Lungrecruitment manoeuver in supine position.
Keywords
Postoperative pulmonary dysfunction, Postoperative pulmonary complication, Recruitment manouver, Prone position
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lungrecruitment manoeuver in prone position.Procedure or surgery

    Also called "Prone Lungrecruitment in ventilator"

    Postoperative lungrecruitment in prone position, pressure-controlled ventilation peak inspiratory pressure 40 cm H2O combined with PEEP 20 cm H2O during 60 seconds.

  • Lungrecruitment manoeuver in supine position.Procedure or surgery

    Also called "Supine Lungrecruitment in ventilator"

    Postoperative lungrecruitment in supine position, pressure-controlled ventilation peak inspiratory pressure 40 cm H2O combined with PEEP 20 cm H2O during 60 seconds.

Study groups in NCT03009331
Study groupRoleWhat they receive
Prone positionExperimentalIntervention: Lungrecruitment in prone position. Device: Ventilator Flow-i, Peak inspiratory pressure 40 cmH2O, PEEP 20 cm H2O during 30 s.
Receives: Procedure: Lungrecruitment manoeuver in prone position.
Supine positionActive comparatorIntervention: Lungrecruitment in supine position. Device: Ventilator Flow-i, Peak inspiratory pressure 40 cmH2O, PEEP 20 cm H2O during 30 s. Clinical routine.
Receives: Procedure: Lungrecruitment manoeuver in supine position.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electrical impedance

    Electrical impedance tomography, thoracical transverse plane measurment. Dräger Pulmovista device is used for collecting the data. Data will be transferred to a personal computer, and processed in Excel.

    Measured: 5 days

  2. Lungcompliance (ml/cm H2O)

    Pulmonary dynamic compliance, ventilator measurment.

    Measured: 2 hours

  3. P/F ratio

    Oxygenation ratio, pO2 divided by FiO2, indication of pulmonary shunt

    Measured: 5 days

  4. Ultrasonography

    Lungultrasound to exclude pleural effusion.

    Measured: 5 days

  5. Chest X-ray

    Chest X-ray to exclude pneumothorax

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study start25 Jul 2017
  3. Primary completion25 Nov 2024
  4. Study completion25 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009331
Sponsor's protocol ID
AMartinssonthorax
Status last verified
May 2025
First submitted
14 Dec 2016
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martinsson A, Houltz E, Wallinder A, Magnusson J, Lindgren S, Stenqvist O, Thoren A. Inspiratory and end-expiratory effects of lung recruitment in the prone position on dorsal lung aeration - new physiological insights in a secondary analysis of a randomised controlled study in post-cardiac surgery patients. BJA Open. 2022 Nov 21;4:100105. doi: 10.1016/j.bjao.2022.100105. eCollection 2022 Dec.

    PubMed 37588783
  • Martinsson A, Houltz E, Wallinder A, Lindgren S, Thoren A. Lung recruitment in the prone position after cardiac surgery: a randomised controlled study. Br J Anaesth. 2021 May;126(5):1067-1074. doi: 10.1016/j.bja.2020.12.039. Epub 2021 Feb 16.

    PubMed 33602580

Questions about this trial

What is this clinical trial studying?

A study testing Lungrecruitment manoeuver in prone position. and Lungrecruitment manoeuver in supine position. in people with Pulmonary Atelectasis, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrical impedance (time frame: 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03009331, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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