Incentive Spirometer in Liver Transplant Recipients

NCT07318766 | Completed

• 1 other identifier: HS000132
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Transplant Disorder

Keywords

Liver Transplant; Incentive Spirometer; Arterial Blood Gas

Outcome Measures

Primary Outcomes (5)

• Arterial blood gas (ABG) parameters

  Arterial pH

  3 days (assessed at four time points: baseline (within 48 hours before surgery) and on post-operative days 1, 2, and 3)

• Arterial Blood Gas (ABG) parameters

  (2) partial pressure of carbon dioxide (PCO2, mmHg)

  3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1,2, and 3 post-surgery)

• Arterial Blood Gas (ABG) parameters

  (3) Partial pressure of oxygen (PO2, mmHg)

  3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)

• Arterial Blood Gas (ABG) Parameters

  (4) bicarbonate concentration (HCO3-, mEq/L)

  3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)

• Arterial Blood Gas (ABG) Parameters

  (5) Oxygen saturation (SpO2, %).

  3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)

Secondary Outcomes (2)

• length of intensive care unit (ICU) stay

  Perioperative period (Hospital stay duration)

• hospital stay

  Perioperative period (Hospital Stay duration)

Study Arms (2)

mobilization and breathing exercises alone

NO INTERVENTION

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.

Incentive Spirometery plus standard exercises

ACTIVE COMPARATOR

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

Device: Incentive Spirometry

Interventions

Incentive Spirometry 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.

Incentive Spirometery plus standard exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• El-Sahel Teaching Hospital: collaborator
• National Hepatology & Tropical Medicine Research Institute: collaborator

Study Sites (1)

El Sahel Teaching hospital

Cairo, Egypt

Location

Study Officials

• Mona A. Abdulmohsen, MD

  El-Sahel Teaching Hospital

  PRINCIPAL INVESTIGATOR

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: Lecturer of Clinical Pharmacy

Model Details: open label, parallel, prospective, randomized study

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 6, 2026
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)