NCT03072784

Brief Summary

Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

February 15, 2017

Last Update Submit

March 7, 2017

Conditions

Bypass ComplicationRespiratory Complication

Outcome Measures

Primary Outcomes (1)

  • quality of oxygenation

    PaO2 mmHg

    48 hours postoperative

Secondary Outcomes (3)

  • time to extubation

    24 hours postoperative

  • ventilation

    48 hours postoperative

  • carbon dioxide

    48 hours

Study Arms (2)

group S

ACTIVE COMPARATOR

short time \<90 m aortic cross clamping

Procedure: aortic cross clamping

group L

ACTIVE COMPARATOR

\> 90 minutes aortic cross clamping

Procedure: aortic cross clamping

Interventions

aortic cross clampingPROCEDURE

duration of cross clamping, less than 90 minutes, or more than 90 minutes

group Lgroup S

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients
  • elective open heart surgery

You may not qualify if:

  • Patients with myocardial ischemia or previous infarction
  • low ejection fraction \<30%
  • history of AF
  • implanted pacemaker
  • uncontrolled hypertension
  • renal impairment (creatinine \>1.8 mg/dl)
  • hepatic dysfunction
  • insulin dependent diabetes
  • chronic pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, Asyut Governorate, 71111, Egypt

Location

Study Officials

  • Emad Z kamel Said, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and critical care Medicine

Study Record Dates

First Submitted

February 15, 2017

First Posted

March 7, 2017

Study Start

February 1, 2015

Primary Completion

April 20, 2016

Study Completion

August 25, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

EG(1)