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Different Modes of Ventilation During Cardiopulmonary Bypass

NCT ID: NCT03824301

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-22

Study Completion Date

2018-11-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pulmonary Dysfunction

Keywords

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cardiopulmonary bypass pressure-controlled ventilation volume-controlled ventilation atelectasis pleural effusion lung compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Volume-controlled ventilation

During cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation

Group Type ACTIVE_COMPARATOR

Volume controlled ventilation

Intervention Type DEVICE

Changing modes of ventilation during cardiopulmonary bypass

Pressure-controlled ventilation

During cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation

Group Type ACTIVE_COMPARATOR

Pressure controlled ventilation

Intervention Type DEVICE

Applying pressure controlled ventilation during cardiopulmonary bypass Period

No ventilation

During cardiopulmonary bypass period the patients were disconnected from ventilator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Volume controlled ventilation

Changing modes of ventilation during cardiopulmonary bypass

Intervention Type DEVICE

Pressure controlled ventilation

Applying pressure controlled ventilation during cardiopulmonary bypass Period

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Anis Metry

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University cardiothoracic hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASCSH32/17

Identifier Type: -

Identifier Source: org_study_id