search
Back to results

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

Primary Purpose

Pulmonary Atelectasis

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lungrecruitment manoeuver in prone position.
Lungrecruitment manoeuver in supine position.
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Atelectasis focused on measuring Postoperative pulmonary dysfunction, Postoperative pulmonary complication, Recruitment manouver, Prone position

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of cardiothoracic anaesthesia, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prone position

Supine position

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Lungcompliance (ml/cm H2O)
Pulmonary dynamic compliance, ventilator measurment.
P/F ratio
Oxygenation ratio, pO2 divided by FiO2, indication of pulmonary shunt
Ultrasonography
Lungultrasound to exclude pleural effusion.
Chest X-ray
Chest X-ray to exclude pneumothorax

Secondary Outcome Measures

Full Information

First Posted
December 14, 2016
Last Updated
December 23, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT03009331
Brief Title
Descriptive and Comparative Study of Respiratory Function in the Postoperative Cardiac Surgery Patient
Official Title
Descriptive and Comparative Study of Respiratory Function in the Postoperative Cardiac Surgery Patient
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
August 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
Postoperative pulmonary dysfunction, Postoperative pulmonary complication, Recruitment manouver, Prone position

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prone position
Arm Type
Experimental
Arm Description
Intervention: Lungrecruitment in prone position. Device: Ventilator Flow-i, Peak inspiratory pressure 40 cmH2O, PEEP 20 cm H2O during 30 s.
Arm Title
Supine position
Arm Type
Active Comparator
Arm Description
Intervention: Lungrecruitment in supine position. Device: Ventilator Flow-i, Peak inspiratory pressure 40 cmH2O, PEEP 20 cm H2O during 30 s. Clinical routine.
Intervention Type
Procedure
Intervention Name(s)
Lungrecruitment manoeuver in prone position.
Other Intervention Name(s)
"Prone Lungrecruitment in ventilator"
Intervention Description
Postoperative lungrecruitment in prone position, pressure-controlled ventilation peak inspiratory pressure 40 cm H2O combined with PEEP 20 cm H2O during 60 seconds.
Intervention Type
Procedure
Intervention Name(s)
Lungrecruitment manoeuver in supine position.
Other Intervention Name(s)
"Supine Lungrecruitment in ventilator"
Intervention Description
Postoperative lungrecruitment in supine position, pressure-controlled ventilation peak inspiratory pressure 40 cm H2O combined with PEEP 20 cm H2O during 60 seconds.
Primary Outcome Measure Information:
Title
Electrical impedance
Description
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.
Time Frame
5 days
Title
Lungcompliance (ml/cm H2O)
Description
Pulmonary dynamic compliance, ventilator measurment.
Time Frame
2 hours
Title
P/F ratio
Description
Oxygenation ratio, pO2 divided by FiO2, indication of pulmonary shunt
Time Frame
5 days
Title
Ultrasonography
Description
Lungultrasound to exclude pleural effusion.
Time Frame
5 days
Title
Chest X-ray
Description
Chest X-ray to exclude pneumothorax
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
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.
Description
Placing a patient in prone position in the immediate postoperative and sedated setting in the Cardiac Intensive Care Unit. Adverse events will be observed and noted by the primary investigator. Adverse events will be divided in less severe (e.g disruption of monitoring, uncoupling of breathing curcuit) and severe (e.g accidental extubation, decubitus ulcers, emergency return to supine position).
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Scheduled cardiac surgery (CABG or valve surgery) Cardiopulmonary bypass Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, Professor
Organizational Affiliation
The Salgrenska Academy
Official's Role
Study Chair
Facility Information:
Facility Name
Department of cardiothoracic anaesthesia, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33602580
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs