NCT03824301

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

January 23, 2019

Last Update Submit

January 30, 2019

Conditions

Postoperative Pulmonary Dysfunction

Keywords

cardiopulmonary bypasspressure-controlled ventilationvolume-controlled ventilationatelectasispleural effusionlung compliance

Outcome Measures

Primary Outcomes (2)

  • chest x-ray

    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

    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.

Study Arms (3)

Volume-controlled ventilation

ACTIVE COMPARATOR

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

Device: Volume controlled ventilation

Pressure-controlled ventilation

ACTIVE COMPARATOR

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

Device: Pressure controlled ventilation

No ventilation

NO INTERVENTION

During cardiopulmonary bypass period the patients were disconnected from ventilator

Interventions

Volume controlled ventilationDEVICE

Changing modes of ventilation during cardiopulmonary bypass

Volume-controlled ventilation
Pressure controlled ventilationDEVICE

Applying pressure controlled ventilation during cardiopulmonary bypass Period

Pressure-controlled ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University cardiothoracic hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary AtelectasisPleural Effusion

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPleural Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 31, 2019

Study Start

January 22, 2017

Primary Completion

March 30, 2018

Study Completion

November 20, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)