NCT06062381

Brief Summary

The goals of this randomized controlled trial are:

  1. 1.To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention.
  2. 2.To compare the gastric residual volume between the intervention and control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

September 25, 2023

Last Update Submit

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

EXPERIMENTAL

experimental group will receive abdominal massage of 20 minutes duration for 3 days.

Procedure: Abdominal Massage

Control Group

NO INTERVENTION

control 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.

Intervention Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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

Locations