Incentive Spirometer in Liver Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-11-01

Brief Summary

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This study evaluated the effect of adjunctive incentive spirometer on arterial blood gases (ABGs) and early postoperative recovery in liver transplant recipients.

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Detailed Description

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In this prospective , randomized study, 40 adults undergoing living-donor liver transplantation (LT) were assigned to standard post-transplant mobilization and breathing exercises alone (n=20) or standard exercises plus structured IS training (n=20). Arterial blood gases ABG parameters (pH, PO₂, PCO₂, HCO₃-, SpO₂) were measured at baseline and on postoperative days 1-3. Linear mixed-effects models assessed group differences in ABG trajectories; slope analyses quantified decline and recovery phases. Secondary outcomes included intensive care unit (ICU) and hospital length of stay (LOS) and Post-operative pulmonary complications incidence.

Conditions

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Liver Transplant Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open label, parallel, prospective, randomized study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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mobilization and breathing exercises alone

Patients in the control group received standard post-transplant mobilization and breathing exercises as per institutional protocol. This included early mobilization, active limb exercises, and deep breathing exercises without the use of an intensive spirometry (IS) device. The exercise regimen was initiated on the first post-operative day and continued throughout the hospital stay.

Group Type NO_INTERVENTION

No interventions assigned to this group

Incentive Spirometery plus standard exercises

Patients in the intervention group received structured training on Incentive spirometry (IS) use commencing on the first post-operative day. A tri-flow volumetric IS device was utilized

Group Type ACTIVE_COMPARATOR

Incentive Spirometry

Intervention Type DEVICE

An intensive spirometry (IS) is a device that measures inhaled air volume and provides visual feedback as a piston rises during inspiration. It is widely used in respiratory and physical therapy to encourage slow, deep breathing, which helps expand the lungs, open airways, and mimic the natural deep breaths seen in yawning or sighing.

Interventions

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Incentive Spirometry

An intensive spirometry (IS) is a device that measures inhaled air volume and provides visual feedback as a piston rises during inspiration. It is widely used in respiratory and physical therapy to encourage slow, deep breathing, which helps expand the lungs, open airways, and mimic the natural deep breaths seen in yawning or sighing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. age between 18 and 65 years,
2. scheduled to undergo Living Donor Liver Transplant (LDLT) as recipients
3. able to understand and follow instructions for incentive spirometry use

Exclusion Criteria

1. multiorgan transplantation
2. moderate-to-severe pleural effusion at baseline
3. persistent elevation in renal function tests
4. history of bleeding esophageal varices within the preceding month
5. multicentric hepatocellular carcinoma (HCC)
6. active smoking
7. decompensated cardiac disease
8. alcoholic hepatitis as the primary etiology
9. cognitive impairment or blindness precluding participation in the rehabilitation protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No