Incentive Spirometer in Liver Transplant Recipients (LT)

Effect of Incentive Spirometer on Arterial Blood Gases in Liver Transplant Recipients

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

Study Overview

• Status: Completed
• Conditions: Liver Transplant Disorder
• Intervention / Treatment: Device: Incentive Spirometry

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • El Sahel Teaching hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of intensive care unit (ICU) stay	The length of intensive care unit (ICU) stay (days)	Perioperative period (Hospital stay duration)
hospital stay	total length of hospital stay (days)	Perioperative period (Hospital Stay duration)

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: El-Sahel Teaching Hospital; National Hepatology & Tropical Medicine Research Institute
• Investigators: Principal Investigator: Mona A. Abdulmohsen, MD, El-Sahel Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Liver Transplant; Arterial Blood Gas; Incentive Spirometer
• Other Study ID Numbers: HS000132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No