the Effect of Abdominal Massage on the Gastric Residual Volume.
The Effect of Abdominal Massage on the Gastric Residual Volume in Adult Patients Admitted in Intensive Care Unit: A Randomized Controlled Trial
1 other identifier
interventional
34
1 country
1
Brief Summary
The goals of this randomized controlled trial are:
- 1.To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention.
- 2.To compare the gastric residual volume between the intervention and control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2024
CompletedMay 17, 2024
May 1, 2024
2 months
September 25, 2023
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Gastric Residual Volume
Gastric residual volume will be measured in ml by aspiration of gastric contents.
before and after intervention ( 3 hours duration)
Study Arms (2)
Intervention Group
EXPERIMENTALexperimental group will receive abdominal massage of 20 minutes duration for 3 days.
Control Group
NO INTERVENTIONcontrol group will receive only routine care
Interventions
The intervention period will be 3 days for intervention group. These patients will receive 20 minutes of abdominal massage twice a day, and the interval between two massages will be 2 hours. The outcome variable variable gastric residual volume will be measured every day, before the intervention and 1 hour after the second massage. the GRV will be measured in ml (via feeding syringe) and marked on checklist. The abdominal massage technique will consist of five steps based on tensegrity principle. The lubricant gel will be used to facilitate the massaging. The patient's position will be supine while going through abdominal massage. The angle between the bed and the patient's head will be 30 to 45 degrees, and the patient's legs will be placed on a pillow. This condition will help to relax the abdominal muscles.
Eligibility Criteria
You may qualify if:
- patients having NG tube (for check the GRV).
- glasgow coma scale less than 7 (because usually these patients need gavage)
- patients having age 18-60 years.
You may not qualify if:
- Patients receiving pro-kinetic medications (to avoid interfering with the massage effects)
- Patients having abdominal radiotherapy during last 6 weeks.
- Patients with abdominal aortic aneurysm and undergoing radiotherapy
- Patients having abdominal surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinnah hospital Lahore
Lahore, Punjab Province, 92000, Pakistan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 25, 2023
First Posted
October 2, 2023
Study Start
November 1, 2023
Primary Completion
January 10, 2024
Study Completion
April 10, 2024
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share