- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07018414
- Original Trial
Abdominal Massage for Gastric Residual Volume in Surgical Patients
The Effect of Abdominal Massage on Gastric Residual Volume and Abdominal Distension in Surgical Intensive Care Patients: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Gastric residual volume (GRV) monitoring is commonly used in critically ill patients receiving enteral nutrition to assess gastrointestinal dysfunction, although current guidelines present conflicting recommendations regarding its necessity. Abdominal distension is a frequent complication during enteral feeding in surgical ICU patients. Non-pharmacological interventions such as abdominal massage have shown promise in improving gastrointestinal motility and enteral tolerance.
This study included 84 surgical ICU patients who met the inclusion criteria and were randomly assigned to intervention (n=42) and control (n=42) groups. The intervention group received abdominal massage twice daily for 20 minutes over three days. Data were collected using standardized forms and analyzed with appropriate statistical tests including independent samples t-test, Mann-Whitney U, repeated measures ANOVA, and chi-square tests. The findings suggest that abdominal massage may help stabilize GRV levels, reduce abdominal circumference, and increase nutritional intake without increasing complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İ̇stanbul
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Istanbul, İ̇stanbul, Turkey, 34230
- Seyrantepe Hamidiye Etfal Training and Research Hospital, Surgical Intensive Care Units
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Receiving enteral nutrition via nasogastric tube
- No prior abdominal surgery
- No invasive devices (e.g., drains, catheters) in the abdominal area
Exclusion Criteria:
- Receiving enteral nutrition via PEG or PEJ
- Receiving only parenteral nutrition
- History of abdominal surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Abdominal Massage Group
Patients in this group received abdominal massage for 20 minutes, twice daily, for three consecutive days after the initiation of enteral nutrition.
|
Non-pharmacological intervention involving manual massage of the abdomen to support gastric motility and reduce gastric residual volume and abdominal distension in enterally fed surgical ICU patients.
|
|
No Intervention: Control Group
Patients in this group received standard postoperative care without abdominal massage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of gastric residual volume (mL)
Time Frame: Day 3
|
Starting from the first day of enteral nutrition, gastric residual volume (mL) will be recorded at regular intervals every day for 3 days.
The amount of GRV changing from the first day to the 3rd day will be measured and analysed.
|
Day 3
|
|
Change in abdominal circumference
Time Frame: Day 3
|
Abdominal circumference will be measured on the first day of enteral feeding and abdominal circumference will be measured every day at the same time for 3 days.
The change in abdominal circumference (cm) from baseline to Day 3 will be recorded.
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of enteral feeding (mL/day)
Time Frame: Day 3
|
The total amount of nutritional product taken on the first day of enteral nutrition will be recorded for 3 days.
The amount taken from the beginning to the 3rd day will be recorded in ml/day.
|
Day 3
|
|
Assessment of abdominal distension
Time Frame: Day 3
|
On the first day of enteral nutrition, abdominal circumference will be measured and abdominal distension will be evaluated by auscultating bowel sounds and daily X-rays.
The presence or absence of abdominal distension from the beginning to the 3rd day will be recorded.
|
Day 3
|
|
Interruption of enteral nutrition
Time Frame: Day 3
|
From the first day of starting enteral nutrition, the reasons for which continuous nutrition is interrupted (for example, going to another unit for radiological examination or re-operation for revision purposes, etc.) will be monitored and recorded for 3 days.
|
Day 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABMGRVSICU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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