NCT02622152

Brief Summary

Directly following cardiac surgery for congenital heart disease; patients are not receiving routine turning every two hours to prevent pressure ulcers, because a negative influence on hemodynamic parameters is assumed. Investigators have suggested that lateral position may have clinically significant effects on oxygenation in cardiac surgery patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

November 28, 2015

Last Update Submit

July 6, 2018

Conditions

Heart Defects, Congenital

Keywords

Right lateralOxygenationCardiacCongenitalPediatricPostoperative

Outcome Measures

Primary Outcomes (1)

  • Arterial oxygenation

    The samples will be analyzed by a blood gas analyzer before and after changing position

    Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days

Secondary Outcomes (4)

  • Blood pressure

    Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days

  • Heart rate

    Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days

  • Oxygen saturation

    Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days

  • Respiratory rate

    Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days

Study Arms (2)

Right lateral position group

ACTIVE COMPARATOR

After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for 30 minutes period on the supine position Repositioning the patients for 30 minutes period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay

Procedure: Right lateral position (2 hours)Procedure: Left lateral position (30 minutes)Procedure: Supine position (30 minutes)

Routine hospital care group

ACTIVE COMPARATOR

After weaning from mechanical ventilation in the postoperative Intensive Care Unit (ICU patient underwent Repositioning the patients for two-hours period on supine position Repositioning the patients for two-hours period on the left lateral position Repositioning the patients for two-hours period on the right lateral position This period of repositioning in both groups repeated during the period of ICU stay

Procedure: Right lateral position (2 hours)Procedure: Left lateral position (2 hours)Procedure: Supine position (2 hours)

Interventions

Right lateral position (2 hours)PROCEDURE

Repositioning the patients for two-hours period on the right lateral position

Right lateral position groupRoutine hospital care group
Left lateral position (30 minutes)PROCEDURE

Repositioning the patients for 30 minutes period on the left lateral position

Right lateral position group
Supine position (30 minutes)PROCEDURE

Repositioning the patients for 30 minutes period on the supine position

Right lateral position group
Left lateral position (2 hours)PROCEDURE

Repositioning the patients for two-hours period on the left lateral position

Routine hospital care group
Supine position (2 hours)PROCEDURE

Repositioning the patients for two-hours period on supine position

Routine hospital care group

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age within 10 years with a cyanotic congenital heart disease
  • Hemodynamic stability with no compromising arrhythmia
  • No respiratory arrest
  • Not connected with mechanical ventilation

You may not qualify if:

  • Cyanotic congenital heart disease
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • sayed abd elshafy, MD

    associate professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sayed abd-elshafy, MD

CONTACT

0020882413203sayed_k_72@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

November 28, 2015

First Posted

December 4, 2015

Study Start

January 30, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations

EG(1)