Different Modes of Ventilation During Cardiopulmonary Bypass

January 30, 2019 updated by: Ayman Anis Metry, Ain Shams University

Comparative Study Between Different Modes of Ventilation During Cardiopulmonary Bypass and Its Effect on Postoperative Pulmonary Dysfunction

66 patients divided into 3 groups with different modes of ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C: control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2), Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University cardiothoracic hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoingvalve surgeries
  • Patients undergoing coronary artery bypass grafting surgeries

Exclusion Criteria:

  • Emergency cases.
  • Off-pump surgeries.
  • Patients with chronic lung diseases with forced expiratory volume in first second (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.
  • Massive blood transfusion during surgery.
  • Complicated surgeries.
  • Redo surgeries.
  • Patients with decompensated heart failure prior to surgery.
  • Patients refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Volume-controlled ventilation
During cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation
Device: Volume controlled ventilation
Changing modes of ventilation during cardiopulmonary bypass
Active Comparator: Pressure-controlled ventilation
During cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation
Device: Pressure controlled ventilation
Applying pressure controlled ventilation during cardiopulmonary bypass Period
No Intervention: No ventilation
During cardiopulmonary bypass period the patients were disconnected from ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chest x-ray
Time Frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
Chest x ray to detect any lung pathology or changes from baseline like pleural effusion, pulmonary edema or pneumonia
after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
lung ultrasonography
Time Frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
Lung ultrasonography to detect any lung changes from baseline or development of consolidation, pulmonary edema or pleural effusion
after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASCSH32/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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