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CompletedNCT05393128Updated Dec 19, 2023

The Effect of Different Positions in Children After Cardiac Surgery

An interventional study of Control group (Supine Position) and Experimental Group (Right Lateral position) in Infant ALL, sponsored by Acibadem University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Month to 1 Year. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Acibadem University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
1 Month to 1 Year
Sex
All
01

Study summary

The objective of this study to determine the effects of giving right lateral, left lateral and supine positions on vital signs and oxygen saturation in children after cardiac surgery.

Read the detailed description

Convenient ventilation management after pediatric cardiac surgery and the positioning of the patient helps to reduce the maximum intrathoracic pressure and venous stasis of the trunk and upper extremities that facilitates the drainage of the blood in the lungs. Due to the fact that the Pre-operative and post-operative management has tremendously changed for the last years, more detailed and up-to-date information is required related to the effect of the body position on the changes of the lung capacities and the pulmonary function. Based on this reason, this research was designed to determine the effect of three different positions as a randomized controlled prospective study.

In case the unit does not contain as routine any obstacle for position (unilateral oedema, ciculation disorder in the extremities, non-bilateral pulmonary atelectasis or dense infiltration, patients who cannot be administered dormicum or fentaver) right lateral, left lateral and supine positions are given. First positioning; also in routine, the standart position given to the first patients is supine position. The patient is first placed supine. Then his arms and legs are supported with support pillows. Transducer level and cuff pressure are controlled, SpO2 probe, ECG probes are controlled. If there's CVK connection, if there isn't any arterial connection, the cuff is controlled and in order to avoid heat loss the patient is covered after controling the body temperature and the position is completed.

In positioning, the 2nd method is right lateral positioning. In this positioning, the patient bed is straightened. Later on, the patient's SpO2 probe, ECG probes, CVK, arterial and cuff connections are once again moved to the right side of the patient and moved from below the patient's body without contact with the body in order to ensure the connections. Then, the patient is turned to right side with angle of 60 or 90 degrees and back is supported with a pillow from the neck to his sacrum, between the legs is also supported with a pillow. Afterwards, the patient's head is elevated with 45 to 60 degrees. Body temperature is controlled. The body is covered in order to avoid temperature loss and position is completed.

The third position that is used is left lateral position. In this positioning, the patient bed is straightened. Then, the patient's SpO2 probe, ECG probe, CVK, artery and cuff connections are transferred to the left side and the connections are made by passing the connections from below the pillow of the patient without touching the body. Later on, The patient is turned to left side with angle of 60 or 90 degrees to the left and the patient's back is supported with pillow from the neck until the sacrum, between the legs is again covered with a pillow. After that, the patient's head is elevated with 45-60 degrees. Body temperature is controlled, covered in order to avoid temperature loss and position is completed.

In this unit, after performing the applications related to the method used, the patient's vital signs and SpO2 are checked and recorded every half hour in the postoperative 24 hours, and hourly in the following processes.

In this study, implementation and data collection for each group will begin after the patient is admitted to the intensive care unit, after stabilization of the surgery (after the 12th hour). Until this time, the patient's follow-up is done in supine position. After stabilization, with the cooperation of the physician, it will continue to be supported by the right lateral and left lateral positions in addition to the supine position every 2 hours. Vital signs and SpO2 values of the patient will be recorded just before positioning, at the 1st minute, 1st hour and its 2nd hour after positioning.

02

Conditions studied

  • Infant ALL

Keywords

  • pediatric heart surgery
  • position
  • infant
03

In context

Lead sponsor

Acibadem University is the lead sponsor of 218 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • First time experiencing congenital cardiovascular surgery,
  • Having Bilateral pulmonary atelectasis assessment,
  • Not having any secondary congenital anomaly or chronic disease,
  • Not having any neurologic symptoms,
  • Being between 1 month - 1 year old
  • Not having bilateral circulatory disorder and not having any obstacle to the position,
  • Being Intubated
  • Receiving 1 mg/kg dormicum, 0,1 mcg/kg fentaver infusion

Exclusion criteria

Exclusion Criteria:

  • Receiving Extra Corporal Membrane Exygenation support,
  • Admitted to ICU with sternum exposed,
  • Receiving Intraaortic balloon pump support,
  • Being a Pre-op period patient,
  • Having a non-bilateral circulatory disorder,
  • Having unilateral thorax drain,
  • Being extubated or being planned for extubation during the study period,
  • Receiving Rocuranium,
  • Not receiving Dormicum or fentaver
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Other
    Control group (Supine position)

    The patient will remain in the supine position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the supine position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change.

    Procedure: Control group (Supine Position)

  • Experimental
    Experimental Group (Right lateral position)

    The patient will remain in the right lateral position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the right lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change.

    Procedure: Experimental Group (Right Lateral position)

  • Experimental
    Experimental Group (Left lateral position)

    The patient will remain in the left lateral position for 2 hours and will be followed up with the physician and nurse. After the patient is given one of the left lateral position, at any time during the 2-hour follow-up period, in case the patient's vital findings and SpO2 levels are beyond the normal findings, in case of a deterioration in the general condition related to the position or another reason, the position will be terminated with the physician's recommendation and the patient will be excluded from the sample. Or except these, in case the physician evaluates the patient and suggests that the position should be changed, the current position will be terminated, and the patient will be excluded from the sample by making a position change.

    Procedure: Experimental Group (Left Lateral position)

Interventions

  • ProcedureControl group (Supine Position)

    In this group the patients will be given supine position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be given supine position. 3. The arms and the hands will be elevated and supported, the legs will be elevated and supported. 4. The patient will be covered. 5. The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.

  • ProcedureExperimental Group (Right Lateral position)

    In this group the patients will be given right lateral position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be positioned supine and the bed will be straightened. 3. Lines, probes will be taken to the right side of the patient and the patient will be turned with 60-90 degrees right lateral and the back will be supported with a pillow along the neck and sacrum. 4. Between the legs will be supported with pillows. 5. The patient's head will be elevated with 45-60 degrees. 6. The patient will be covered : 7. The patient's vital signs, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.

  • ProcedureExperimental Group (Left Lateral position)

    In this group the patients will be given left lateral position. 1. Body temperature, heart rate, respiration rate, blood pressure, oxygen saturation and CVP will be recorded before the process. 2. The patient will be positioned supine and the bed will be straightened. 3. Lines, probes will be taken to the left side of the patient and the patient will be turned with 60-90 degrees left lateral and the back will be supported with a pillow along the neck and sacrum. 4. Between the legs will be supported with pillows. 5. The patient's head will be elevated with 45-60 degrees. 6. The patient will be covered : 7. The patient's vital findings, SpO2 levels will be registered right before giving position, on the 1st minute, on the 1st hour and on the 2nd hour from right after giving position.

06

What researchers measure

Primary outcomes

  1. Change in Body Temperature

    This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary.

    Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

  2. Change in Heart Rate

    Heart rate will be monitored.

    Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

  3. Change in Blood Pressure

    Blood Pressure will be monitored.

    Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

  4. Change in Respiratory Rate

    Respiratory rate will be monitored.

    Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

  5. Change in Oxygen Saturation

    Oxygen Saturation will be monitored.

    Time frame: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

07

Study locations

1 site
  • Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Education and Research Hospital
    Istanbul, Kadıköy 34734, Turkey (Türkiye)
08

References and documents

Publications

  • Silva ME, Feuser MR, Silva MP, Uhlig S, Parazzi PL, Rosa GJ, Schivinski CI. Pediatric cardiac surgery: what to expect from physiotherapeutic intervention? Rev Bras Cir Cardiovasc. 2011 Apr-Jun;26(2):264-72. doi: 10.1590/s0102-76382011000200018. English, Portuguese. PubMed 21894418 ↗
  • Thomas PJ, Paratz JD. Is there evidence to support the use of lateral positioning in intensive care? A systematic review. Anaesth Intensive Care. 2007 Apr;35(2):239-55. doi: 10.1177/0310057X0703500214. PubMed 17444315 ↗
  • de Laat E, Schoonhoven L, Grypdonck M, Verbeek A, de Graaf R, Pickkers P, van Achterberg T. Early postoperative 30 degrees lateral positioning after coronary artery surgery: influence on cardiac output. J Clin Nurs. 2007 Apr;16(4):654-61. doi: 10.1111/j.1365-2702.2006.01715.x. PubMed 17402946 ↗
  • Hickey PA, Pasquali SK, Gaynor JW, He X, Hill KD, Connor JA, Gauvreau K, Jacobs ML, Jacobs JP, Hirsch-Romano JC. Critical Care Nursing's Impact on Pediatric Patient Outcomes. Ann Thorac Surg. 2016 Oct;102(4):1375-80. doi: 10.1016/j.athoracsur.2016.03.019. Epub 2016 May 10. PubMed 27173065 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05393128
Responsible party
Zehra Kan Onturk (Principal Investigator Assist. Prof., Acibadem University) — Principal investigator
First posted
May 26, 2022
Start date
Mar 17, 2022
Primary completion
Jun 20, 2023
Completion
Jun 20, 2023
Last update
Dec 19, 2023

Study contacts

Zehra Kan Öntürk, Assist Prof
principal investigator · Acibadem University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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