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

NCT03009331 | Completed

• 1 other identifier: AMartinssonthorax
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Atelectasis

Keywords

Postoperative pulmonary dysfunction; Postoperative pulmonary complication; Recruitment manouver; Prone position

Outcome Measures

Primary Outcomes (5)

• 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.

  5 days

• Lungcompliance (ml/cm H2O)

  Pulmonary dynamic compliance, ventilator measurment.

  2 hours

• P/F ratio

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

  5 days

• Ultrasonography

  Lungultrasound to exclude pleural effusion.

  5 days

• Chest X-ray

  Chest X-ray to exclude pneumothorax

  5 days

Other Outcomes (1)

• Safety and Tolerability of prone position (turned 180 dgrees from supine position, Intensive Care Unit Bed), number of adverse events observed by the primary investigator.

  2 hours

Study Arms (2)

Prone position

EXPERIMENTAL

Intervention: Lungrecruitment in prone position. Device: Ventilator Flow-i, Peak inspiratory pressure 40 cmH2O, PEEP 20 cm H2O during 30 s.

Procedure: Lungrecruitment manoeuver in prone position.

Supine position

ACTIVE COMPARATOR

Intervention: Lungrecruitment in supine position. Device: Ventilator Flow-i, Peak inspiratory pressure 40 cmH2O, PEEP 20 cm H2O during 30 s. Clinical routine.

Procedure: Lungrecruitment manoeuver in supine position.

Interventions

Lungrecruitment manoeuver in prone position. PROCEDURE

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

Also known as: "Prone Lungrecruitment in ventilator"

Prone position

Lungrecruitment manoeuver in supine position. PROCEDURE

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

Also known as: "Supine Lungrecruitment in ventilator"

Supine position

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of cardiothoracic anaesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• 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.

  PMID: 37588783 DERIVED

• 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.

  PMID: 33602580 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Prone Position; Ventilators, Mechanical; Supine Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Equipment and Supplies

Study Officials

• Sven-Erik Ricksten, Professor

  The Salgrenska Academy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 4, 2017
• Study Start: July 25, 2017
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)