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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03009331
Other study ID # AMartinssonthorax
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 25, 2017
Est. completion date November 15, 2025

Study information

Verified date November 2023
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Department of cardiothoracic anaesthesia, Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. 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). 2 hours
Primary 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
Primary Lungcompliance (ml/cm H2O) Pulmonary dynamic compliance, ventilator measurment. 2 hours
Primary P/F ratio Oxygenation ratio, pO2 divided by FiO2, indication of pulmonary shunt 5 days
Primary Ultrasonography Lungultrasound to exclude pleural effusion. 5 days
Primary Chest X-ray Chest X-ray to exclude pneumothorax 5 days
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