Heart Defects, CongenitalNCT02622152
Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery
A study testing Right lateral position (2 hours), Left lateral position (30 minutes) and Supine position (30 minutes) in people with Heart Defects, Congenital, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Right lateral position (2 hours), Left lateral position (30 minutes) and Supine position (30 minutes)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age within 10 years with a cyanotic congenital heart disease
- Hemodynamic stability with no compromising arrhythmia
- No respiratory arrest
- Not connected with mechanical ventilation
Who cannot join
- Cyanotic congenital heart disease
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut
mohamed abdelatef, MD, 0020882413201, latif_mohamed@hotmail.com
About this study
Official title: Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery: Effect on Arterial Oxygenation, Respiratory Mechanics, Hemodynamics, and Adverse Events
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.
Read the detailed description
Sixty pediatric congenital heart disease patients were randomly assigned to two equal intervention groups
- Conditions
- Heart Defects, Congenital
- Being tested
- Right lateral position (2 hours), Left lateral position (30 minutes), Supine position (30 minutes), Left lateral position (2 hours), Supine position (2 hours)
- Keywords
- Right lateral, Oxygenation, Cardiac, Congenital, Pediatric, Postoperative
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right lateral position (2 hours)Procedure or surgery
Repositioning the patients for two-hours period on the right lateral position
Left lateral position (30 minutes)Procedure or surgery
Repositioning the patients for 30 minutes period on the left lateral position
Supine position (30 minutes)Procedure or surgery
Repositioning the patients for 30 minutes period on the supine position
Left lateral position (2 hours)Procedure or surgery
Repositioning the patients for two-hours period on the left lateral position
Supine position (2 hours)Procedure or surgery
Repositioning the patients for two-hours period on supine position
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Right lateral position (2 hours); Procedure: Left lateral position (2 hours); Procedure: Supine position (2 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygenation
The samples will be analyzed by a blood gas analyzer before and after changing position
Measured: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Secondary outcomes (4)
Blood pressure
Systolic, diastolic and mean blood pressure " mm Hg"
Measured: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Heart rate
Heart rate "beats per minute"
Measured: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Oxygen saturation
Oxygen saturation %
Measured: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Respiratory rate
Respiratory rate "rate per minute"
Measured: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start30 Jan 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, MD, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622152
- Sponsor's protocol ID
- IRB0000871200
- Status last verified
- Jul 2018
- First submitted
- 28 Nov 2015
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery: Effect on Arterial Oxygenation, Respiratory Mechanics, Hemodynamics, and Adverse Events
- ClinicalTrials.gov ID
- NCT02622152
- Acronym / sponsor ID
- IRB0000871200
- Conditions
- Heart Defects, Congenital
- Keywords
- Right lateral, Oxygenation, Cardiac, Congenital, Pediatric, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sixty pediatric congenital heart disease patients were randomly assigned to two equal intervention groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right lateral position group | Active comparator | Procedure: Right lateral position (2 hours), Procedure: Left lateral position (30 minutes), Procedure: Supine position (30 minutes)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 |
| Routine hospital care group | Active comparator | Procedure: Right lateral position (2 hours), Procedure: Left lateral position (2 hours), Procedure: Supine position (2 hours)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 |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age within 10 years with a cyanotic congenital heart disease
- Hemodynamic stability with no compromising arrhythmia
- No respiratory arrest
- Not connected with mechanical ventilation
Key exclusion criteria (2 listed)
- Cyanotic congenital heart disease
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right lateral position (2 hours)Repositioning the patients for two-hours period on the right lateral position | Procedure or surgery | Right lateral position group, Routine hospital care group |
| Left lateral position (30 minutes)Repositioning the patients for 30 minutes period on the left lateral position | Procedure or surgery | Right lateral position group |
| Supine position (30 minutes)Repositioning the patients for 30 minutes period on the supine position | Procedure or surgery | Right lateral position group |
| Left lateral position (2 hours)Repositioning the patients for two-hours period on the left lateral position | Procedure or surgery | Routine hospital care group |
| Supine position (2 hours)Repositioning the patients for two-hours period on supine position | Procedure or surgery | Routine hospital care group |
Primary outcome
Arterial oxygenation
Time frame: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
The samples will be analyzed by a blood gas analyzer before and after changing position
4 secondary outcomes
Blood pressure
Time frame: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Heart rate
Time frame: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Oxygen saturation
Time frame: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Respiratory rate
Time frame: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sayed abd elshafy, MD principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right lateral position (2 hours), Left lateral position (30 minutes) and Supine position (30 minutes) in people with Heart Defects, Congenital, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sayed abd-elshafy, MD (0020882413203, sayed_k_72@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygenation (time frame: Duration of Intensive Care Unit Admission after weaning from mechanical ventilation an expected average of 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.