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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04841174
Other study ID # 202173
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2021
Source Istanbul University-Cerrahpasa
Contact Sümeyye Kalayci
Phone +905389892329
Email sumeyye.akalyci@ogr.iuc.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many system functions differ in children dependent on mechanical ventilation support and may present with various complications. In the gastrointestinal system, gastric and duodenum-related decreased motility disorders are a very common problem in critically ill patients hospitalized in the intensive care unit, which increases mortality and morbidity. The prevalence of gastric dysmotility in pediatric intensive care is estimated to be 50%. Gastric problems such as vomiting, increase in the amount of gastric residue, decrease in bowel movements, abdominal distension, diarrhea/ constipation, etc. are observed as a result of the dysfunction of the gastrointestinal system. In addition to these problems; there are problems associated with the ventilator such as pneumonia, infection, bacterial growth, and stopping enteral feeding. Malnutrition as a result of stopping feeding prolongs the hospitalization of intensive care patients and affects mortality. Intensive care nurses play a key role in providing nutritional support to patients who receive mechanical ventilation support and whose level of consciousness is reduced. Intensive care nurses have many responsibilities such as timely initiation of nutrition, application of correct nutrition, correct placement of feeding tubes, and prevention of problems that may arise as a result of nutrition. Abdominal massage practice is a therapeutic, independent, and evidence-based nursing intervention. It has been used for many years to increase the motility of the gastrointestinal system and to treat constipation. Inexpensive and easy to apply abdominal massage compared to other methods; It increases intestinal motility, accelerates the mechanical advancement of nutrients in the digestive system, improves the blood flow of the region, and is effective in reducing intra-abdominal pressure. It has been reported in the literature that abdominal massage applied to preterm babies increases nutritional tolerance. Studies on adults have also reported that gastric residue is reduced, less vomiting is experienced, and abdominal distension is less common. However, there is no study examining the effects of abdominal massage in reducing gastrointestinal problems in children hospitalized in pediatric intensive care units and receiving ventilator support. Therefore, the aim of this study is to examine the effect of abdominal massage on gastric problems in children who are fed enterally in the pediatric intensive care unit.


Description:

According to Espen (European Society for Clinical Nutrition and Metabolism) intensive care nutrition guide; in critically ill patients under mechanical ventilation support, early enteral feeding (24-48 hours) is recommended. Nutrition, which is an important part of intensive care treatment; accelerates wound healing in critically ill patients, regulates the immune system, decreases mortality rates, and plays a role in shortening hospital stay. As a result of the early initiation of enteral feeding, the gastrointestinal system barrier mechanisms are preserved and mucosal atrophies are prevented. Gastrointestinal, mechanical, and metabolic complications may occur in patients who are fed enterally in an intensive care unit and feeding is interrupted in these cases. Studies have shown that problems such as diarrhea, constipation, abdominal distension, aspiration pneumonia, increased gastric residual volume, and feeding intolerance occur in patients in whom enteral feeding is initiated. As a result of a study conducted with 341 children connected to mechanical ventilation, it was found that only 66.6% of the children reached their daily enteral nutrition goals on the 7th day of their hospitalization. Massage has been used as therapeutic treatment in medicine for many years. Abdominal massage stimulates the digestive system and increases peristaltic movements. It is thought to accelerate food passage and digestion because it causes mechanical and reflexive movements in the intestines. In adult age group studies where, abdominal massage is applied; It has been reported that there is less aspiration pneumonia, the gastric residue is reduced, less vomiting is experienced and abdominal distension is less common. Similar results are seen in studies with preterm babies. It has been reported that gastric residual volume decreases, the frequency of defecation increases, and less vomiting is observed in preterm babies who are massaged. In a meta-analysis study by Biarag and Mirghafourvand, it was reported that abdominal massage reduced the frequency of vomiting and less gastric residue was removed in preterm babies. In the study conducted by Kim, it is seen that preterm babies who were massaged started enteral feeding before. In addition, it has been reported that massage helps weight gain in preterms by increasing nutritional tolerance. There is no study in the literature on the effect of abdominal massage on critical patients in pediatric intensive care, and studies are needed in this area.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 24 Months
Eligibility Inclusion Criteria: - The child's family volunteering to the research - The ages of the children participating in the study are between 30 days and 24 months. - At least 48 hours of mechanical ventilation support - Beginning of enteral feeding and at least 24 hours have passed since - Feeding with a nasogastric tube - Very low, low or moderate mortality score according to the PRISM III score - Not having had abdominal surgery Exclusion Criteria: - High or very high mortality score compared to the PRISM III score - Anatomically, the absence of gastrointestinal system integrity Having a gastrostomy or stoma Having a tracheostomy - Inotrope receiving treatment - Hemodynamics is not stable - Intracranial bleeding, increased intracranial pressure, cranial tumor, etc. having a severe neurological problem, such as

Study Design


Intervention

Other:
Abdominal massage
The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined.

Locations

Country Name City State
Turkey Bakirkoy Dr. Sadi Konuk Training and Research Hospital Bakirköy Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

Badini Pourazar, S., Shirinabadi Farahani, A., Ghahri Sarabi, A., Pourhoseingholi, M. A. ve Dehghan, K. The Effect Of Abdominal Touch On Nutritional Tolerance In Premature Infants: A Randomized Controlled Clinical Trail. International Journal Of Pediatrics, 2018; 6(8): 8119-8128.

Citak, A., Kalkan, G., Anil, A. B., Agin, H., Akyildiz, B. N., Dursun, O. & Yildizdas, D. (2018). Pediatric Acute Respiratory Distress Syndrome (PARDS) Protocol. http://cayd.org.tr/files/pediatrik-akut-respiratuar-distres-sendromu-pards-protokolu-0p.pdf

Dehghan M, Fatehi Poor A, Mehdipour-Rabori R, Ahmadinejad M. Effect of abdominal massage on prevention of aspiration in intubated and enterally fed patients: A randomized controlled trial. J Complement Integr Med. 2020 Sep 23;17(3). doi: 10.1515/jcim-2017-0124. — View Citation

Demiray, A, Kuzyaka, I, Açil, A, Ilaslan, N. Evaluation of Intensive Care Patients with Enteral Nutrition in Terms of Nutrition Process and Possible Complications. Düzce University Institute of Health Sciences Journal. 2020; 10 (3), 289-296. DOI: 10.33631 / duzcesbed.599143

Fruhwald S, Holzer P, Metzler H. Intestinal motility disturbances in intensive care patients pathogenesis and clinical impact. Intensive Care Med. 2007 Jan;33(1):36-44. Epub 2006 Nov 18. Review. — View Citation

Ghasemi, M., Najafian, B., Khosravi, M., Nekavand, M. Effect of Abdominal Massage on Gastric Residual Volume and Weight Gain of Premature Infants Admitted in NICU. Canon Journal of Medicine. 2019; 1(2), 49-54. doi: 10.30477/cjm.2019.87285

Gürkan A, Gülseven B. ENTERAL NUTRITION: CURRENT APPROACHES TO CARE. Anatolian Journal of Nursing and Health Sciences. 2013; 16 (2): 116-122.

Haghshenas Mojaveri, M., Jafarian Amiri, S. R., Dalili, H., Khafri, S. ve Hamed, F. The Effect Of Abdominal Massage On The Feeding Tolerance Of Neonates With Very Low Birth Weight. Iranian Journal Of Pediatrics. 2020; 30(2).

Kim HY, Bang KS. The effects of enteral feeding improvement massage on premature infants: A randomised controlled trial. J Clin Nurs. 2018 Jan;27(1-2):92-101. doi: 10.1111/jocn.13850. Epub 2017 Jun 28. — View Citation

Koçhan, E. And Akin, S. Evaluation of Nurses' Knowledge Level Regarding Enteral and Parenteral Nutrition Practices. J Acad Res Nurs, JAREN. 2018; 4 (1), 1-14.

Martinez EE, Bechard LJ, Mehta NM. Nutrition algorithms and bedside nutrient delivery practices in pediatric intensive care units: an international multicenter cohort study. Nutr Clin Pract. 2014 Jun;29(3):360-7. doi: 10.1177/0884533614530762. Epub 2014 Apr 16. — View Citation

Martinez EE, Douglas K, Nurko S, Mehta NM. Gastric Dysmotility in Critically Ill Children: Pathophysiology, Diagnosis, and Management. Pediatr Crit Care Med. 2015 Nov;16(9):828-36. doi: 10.1097/PCC.0000000000000493. Review. — View Citation

Momenfar F, Abdi A, Salari N, Soroush A, Hemmatpour B. Studying the effect of abdominal massage on the gastric residual volume in patients hospitalized in intensive care units. J Intensive Care. 2018 Aug 10;6:47. doi: 10.1186/s40560-018-0317-5. eCollection 2018. — View Citation

Rad, Z. A., Haghshenas, M., Javadian, Y., Hajiahmadi, M., & Kazemian, F. The Effect Of Massage On Weight Gain In Very Low Birth Weight Neonates. Journal Of Clinical Neonatology. 2016; 5(2), 96.

Savran, Y., Limon, M., Tokur, M. E. ve Cömert, B. Factors Associated With Insufficient Nutrition And Effects Of Timely Adequate Nutrition Support On Patient Outcomes In Intubated Adult Intensive Care Unit Patients. Journal Of Medical And Surgical Intensive Care Medicine. 2016; 7(1), 15-21.

Seiiedi-Biarag L, Mirghafourvand M. The effect of massage on feeding intolerance in preterm infants: a systematic review and meta-analysis study. Ital J Pediatr. 2020 Apr 23;46(1):52. doi: 10.1186/s13052-020-0818-4. — View Citation

Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29. — View Citation

Tekin, E., Akan, M., Koca, U., Adiyaman, E., Gökmen, A. N., Özkardesler, S. and Kiliçaslan, N. Comparison of Different Gastric Residual Volumes in Intensive Care Patients Receiving Enteral Nutrition. Turkish Journal of Intensive Care. 2019; 17 (1), 25-30.

Terzi, B., and Kökcü, Ö. D. Different Views on Measuring Gastric Residual Volume in Patients Fed Enterally in the Intensive Care Unit. Journal Of Human Rhythm. 2019; 5 (4), 344-351.

Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of intra abdominal pressure measurement compared to abdominal massage Data will be collected in line with the intra-abdominal pressure measurement protocol created by the researcher. Measurements will be made with the help of a bladder catheter that is present in the patient. The measurement will be repeated before and after the massage. Three days
Primary Variation of gastric residue measurement compared to abdominal massage The gastric residue will be checked by the nurses with a feeding syringe and recorded on the investigation form. Before each feeding, gastric residue will be checked. Before and after the massage results will be compared. Three days
Primary Measurement of abdominal circumference in centimeters The abdominal circumference of the patient is measured with the help of a tape measure. Three days
Primary Bowel sounds in minutes / numbers Bowel sounds are listened to with a stethoscope on four quadrants for one minute. Three days
Primary Presence of abdominal distension The abdomen of the patient is examined manually and evaluated in terms of distension. Three days
Primary Presence of defect in terms of days / frequency It is recorded how many times the patient defecated during the day. Three days
Primary Presence of vomiting in terms of days / frequency How many times the patient vomited during the day is recorded. Three days
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