Incentive Spirometer in Liver Transplant Recipients (LT)

December 19, 2025 updated by: Aya Mohammed Abdel Magid Abdel Hamid, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • El Sahel Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arterial blood gas (ABG) parameters
Time Frame: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and on post-operative days 1, 2, and 3)
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
Time Frame: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1,2, and 3 post-surgery)
(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
Time Frame: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)
(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
Time Frame: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)
(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
Time Frame: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)
(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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
length of intensive care unit (ICU) stay
Time Frame: Perioperative period (Hospital stay duration)
The length of intensive care unit (ICU) stay (days)
Perioperative period (Hospital stay duration)
hospital stay
Time Frame: Perioperative period (Hospital Stay duration)
total length of hospital stay (days)
Perioperative period (Hospital Stay duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
El-Sahel Teaching Hospital
National Hepatology & Tropical Medicine Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mona A. Abdulmohsen, MD, El-Sahel Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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