Infant ALLNCT04454294
Determining the Effect of Two Different Methods in Children to Maintain Drain Patency After Cardiac Surgery
A study testing Experimental Group (Absorption Group) and Experimental Group (Milking Group) in people with Infant ALL and Congenital Heart Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the effect of the use of milking and sucking methods on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal drains after cardiac surgery. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Infant ALL, Congenital Heart Disease
- What is being tested?
- Experimental Group (Absorption Group) and Experimental Group (Milking Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2018to 12 Dec 2019
- 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 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Parents / legal guardian agree to participate in the study and sign the informed consent form,
- Having undergone congenital cardivascular surgery for the first time,
- Chest and / or mediastinal drain after cardiac surgery,
- Without secondary congenital anomaly and chronic disease,
- No neurological symptoms,
- No sepsis,
- 1 month - 1 year old age group,
- Anticoagulant use after surgery and during research,
Who cannot join
- Receiving extra corporal membrane oxygenation support,
- Sternum admitted to open intensive care,
- Receiving intraaortic balloon pump support,
- Reoperative
- Complicated cases with bleeding diathesis and thought to be highly drained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effect of Two Different Methods on Bleeding, Vital Signs and Oxygen Saturation in Children to Maintain Drain Patency After Cardiac Surgery
In this study, it was aimed to determine the effect of the use of milking and sucking methods on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal drains after cardiac surgery.
Read the detailed description
The patient admitted to the post-operative Cardiovascular Surgery Intensive Care Units primarily meets two nurses and is responsible for the arrangement of medical equipment, monitoring, monitoring, maintaining, recording, and performing the necessary treatments. Then the nurse positions the drain after checking the drain connections, checks the level of the drain and records it in the nurse follow-up note. Then, the method to be used in maintaining the drain opening is decided in cooperation with the physician.
Three different methods are currently used in the unit. The first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample.
The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system.
The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part.
After the applications related to the method to be used are performed, the patient's vital signs, Sp02 and bleeding amount are generally monitored every hour.
In this study, the data for each group will be collected before and after the procedure for 6 hours after surgery, from the moment the patient is admitted to the intensive care unit.
- Conditions
- Infant ALL, Congenital Heart Disease
- Being tested
- Control, Experimental Group (Absorption Group), Experimental Group (Milking Group)
- Keywords
- infant, congenital heart disease, drain patency, nursing
- 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.
ControlOther
Common Process Steps:
- Informed consent forms will be signed by those who wish to take part in the research.
- The form in which individual characteristics are questioned will be filled.
- Hands will be washed, gloves will be worn.
- Before the procedure, body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and bleeding amount will be recorded.
- Drains will be kept parallel to the ground and upright.
- Drainage hoses will not be bent and in-bed position will be provided in accordance with gravity.
- It will be ensured that all connections between the chest tubes and drainage unit are tight and secure.
- Dressings of the chest and mediastinum drains will be fixed on the patient's skin, so as not to interfere with drainage.
- To prevent the tubes from coming out, they will be fixed to the patient bed.
Vital signs, Sp02 and bleeding amount will be recorded every hour for 6 hours after surgery
Experimental Group (Absorption Group)Other
- Common process steps
- Appropriate negative pressure monitoring system of the patient, who is admitted to the intensive care unit with underwater drainage system, will be established.
- The suction control room combined with the vacuum regulator will be filled with sterile distilled water up to the specified level (20 cm H2O).
- From the vacuum regulator, the drain or drains will be connected tightly and by preventing the crimping, from the aspirator receptor hoses.
- Suction will begin with a low level and gradually increase the suction until a slight bubble is noticed in the suction control room.
- Suction pressure will be maintained between 5 and 15 kPa (kilopascals) or 10-20 cm H20.
- The application will continue without interruption until the patient's drain need and the doctor's request is ended.
- During the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.
Experimental Group (Milking Group)Other
- Common process steps will be applied
- Operation will start from the area near the drain entrance point
- Latex tube will be folded into 12 cm long pieces and will be gripped with two hands
- The procedure will be repeated 3 times by compressing the parts gripped by the nurse hand.
- This process will be repeated in the distal part.
- After the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | The first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample. Receives: Other: Control |
| Experimental Group (Absorption Group) | Experimental | The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system. Receives: Other: Experimental Group (Absorption Group) |
| Experimental Group (Milking Group) | Experimental | The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part. Receives: Other: Experimental Group (Milking Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary. The data for each group will be collected before and after the procedure for 6 hours after surgery
Measured: 6 hours after surgery
Heart rate
This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Measured: 6 hours after surgery
Respiratory rate
This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Measured: 6 hours after surgery
Blood pressure
This outcome contains both systolic and diastolic blood pressure. Blood pressure measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Measured: 6 hours after surgery
Oxygen saturation
This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Measured: 6 hours after surgery
Bleeding amount
This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery
Measured: 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start28 Jul 2018
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infant ALLStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Zehra Kan Öntürk, Ass. Prof., Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454294
- Sponsor's protocol ID
- ATADEK 2018/11
- Status last verified
- Aug 2021
- First submitted
- 25 Jun 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x.
PubMed 19740284Cook M, Idzior L, Bena JF, Albert NM. Nurse and patient factors that influence nursing time in chest tube management early after open heart surgery: A descriptive, correlational study. Intensive Crit Care Nurs. 2017 Oct;42:116-121. doi: 10.1016/j.iccn.2017.03.008. Epub 2017 Apr 28.
PubMed 28457690Lu C, Jin YH, Gao W, Shi YX, Xia X, Sun WX, Tang Q, Wang Y, Li G, Si J. Variation in nurse self-reported practice of managing chest tubes: A cross-sectional study. J Clin Nurs. 2018 Mar;27(5-6):e1013-e1021. doi: 10.1111/jocn.14127. Epub 2018 Feb 21.
PubMed 29076204Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. No abstract available.
PubMed 17962505Sullivan B. Nursing management of patients with a chest drain. Br J Nurs. 2008 Mar 27-Apr 9;17(6):388-93. doi: 10.12968/bjon.2008.17.6.28906.
PubMed 18414310
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Two Different Methods on Bleeding, Vital Signs and Oxygen Saturation in Children to Maintain Drain Patency After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04454294
- Acronym / sponsor ID
- ATADEK 2018/11
- Conditions
- Infant ALL, Congenital Heart Disease
- Keywords
- infant, congenital heart disease, drain patency, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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.
In this study, it was aimed to determine the effect of the use of milking and sucking methods on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal drains after cardiac surgery.
Detailed description
The patient admitted to the post-operative Cardiovascular Surgery Intensive Care Units primarily meets two nurses and is responsible for the arrangement of medical equipment, monitoring, monitoring, maintaining, recording, and performing the necessary treatments. Then the nurse positions the drain after checking the drain connections, checks the level of the drain and records it in the nurse follow-up note. Then, the method to be used in maintaining the drain opening is decided in cooperation with the physician.
Three different methods are currently used in the unit. The first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample.
The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system.
The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part.
After the applications related to the method to be used are performed, the patient's vital signs, Sp02 and bleeding amount are generally monitored every hour.
In this study, the data for each group will be collected before and after the procedure for 6 hours after surgery, from the moment the patient is admitted to the intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlThe first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample. |
| Experimental Group (Absorption Group) | Experimental | Other: Experimental Group (Absorption Group)The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system. |
| Experimental Group (Milking Group) | Experimental | Other: Experimental Group (Milking Group)The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- -Parents / legal guardian agree to participate in the study and sign the informed consent form,
- Having undergone congenital cardivascular surgery for the first time,
- Chest and / or mediastinal drain after cardiac surgery,
- Without secondary congenital anomaly and chronic disease,
- No neurological symptoms,
Key exclusion criteria (5 listed)
- Receiving extra corporal membrane oxygenation support,
- Complicated cases with bleeding diathesis and thought to be highly drained
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 |
|---|---|---|
| ControlCommon Process Steps: 1. Informed consent forms will be signed by those who wish to take part in the research. 2. The form in which individual characteristics are questioned will be filled. 3. Hands will be washed, gloves will be worn. 4. Before the procedure, body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and bleeding amount will be recorded. 5. Drains will be kept parallel to the ground and upright. 6. Drainage hoses will not be bent and in-bed position will be provided in accordance with gravity. 7. It will be ensured that all connections between the chest tubes and drainage unit are tight and secure. 8. Dressings of the chest and mediastinum drains will be fixed on the patient's skin, so as not to interfere with drainage. 9. To prevent the tubes from coming out, they will be fixed to the patient bed. Vital signs, Sp02 and bleeding amount will be recorded every hour for 6 hours after surgery | Other | Control |
| Experimental Group (Absorption Group)1. Common process steps 2. Appropriate negative pressure monitoring system of the patient, who is admitted to the intensive care unit with underwater drainage system, will be established. * The suction control room combined with the vacuum regulator will be filled with sterile distilled water up to the specified level (20 cm H2O). * From the vacuum regulator, the drain or drains will be connected tightly and by preventing the crimping, from the aspirator receptor hoses. 3. Suction will begin with a low level and gradually increase the suction until a slight bubble is noticed in the suction control room. 4. Suction pressure will be maintained between 5 and 15 kPa (kilopascals) or 10-20 cm H20. 5. The application will continue without interruption until the patient's drain need and the doctor's request is ended. 6. During the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method. | Other | Experimental Group (Absorption Group) |
| Experimental Group (Milking Group)1. Common process steps will be applied 2. Operation will start from the area near the drain entrance point 3. Latex tube will be folded into 12 cm long pieces and will be gripped with two hands 4. The procedure will be repeated 3 times by compressing the parts gripped by the nurse hand. 5. This process will be repeated in the distal part. 6. After the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method. | Other | Experimental Group (Milking Group) |
Primary outcome
Body temperature
Time frame: 6 hours after surgery
This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary. The data for each group will be collected before and after the procedure for 6 hours after surgery
Heart rate
Time frame: 6 hours after surgery
This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Respiratory rate
Time frame: 6 hours after surgery
This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Blood pressure
Time frame: 6 hours after surgery
This outcome contains both systolic and diastolic blood pressure. Blood pressure measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Oxygen saturation
Time frame: 6 hours after surgery
This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery
Bleeding amount
Time frame: 6 hours after surgery
This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Background: PubMed 19740284Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x.
- Background: PubMed 28457690Cook M, Idzior L, Bena JF, Albert NM. Nurse and patient factors that influence nursing time in chest tube management early after open heart surgery: A descriptive, correlational study. Intensive Crit Care Nurs. 2017 Oct;42:116-121. doi: 10.1016/j.iccn.2017.03.008. Epub 2017 Apr 28.
- Background: PubMed 29076204Lu C, Jin YH, Gao W, Shi YX, Xia X, Sun WX, Tang Q, Wang Y, Li G, Si J. Variation in nurse self-reported practice of managing chest tubes: A cross-sectional study. J Clin Nurs. 2018 Mar;27(5-6):e1013-e1021. doi: 10.1111/jocn.14127. Epub 2018 Feb 21.
- Background: PubMed 17962505Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. No abstract available.
- Background: PubMed 18414310Sullivan B. Nursing management of patients with a chest drain. Br J Nurs. 2008 Mar 27-Apr 9;17(6):388-93. doi: 10.12968/bjon.2008.17.6.28906.
- Individual participant dataSharing planned: No
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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.
Zehra Kan Öntürk, Ass. Prof. principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (Absorption Group) and Experimental Group (Milking Group) in people with Infant ALL and Congenital Heart Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 26 Aug 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: 6 hours after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454294, which also lists 5 linked publications.
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 26 Aug 2021.