Liver Transplant DisorderLTNCT07318766
Incentive Spirometer in Liver Transplant Recipients
A study testing Incentive Spirometry in people with Liver Transplant Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluated the effect of adjunctive incentive spirometer on arterial blood gases (ABGs) and early postoperative recovery in liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- Incentive Spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- decompensated cardiac disease
- alcoholic hepatitis as the primary etiology
- cognitive impairment or blindness precluding participation in the rehabilitation protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplant Disorder
- Being tested
- Incentive Spirometry
- Keywords
- Liver Transplant, Incentive Spirometer, Arterial Blood Gas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive SpirometryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Incentive Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gas (ABG) parameters
Arterial pH
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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, %).
Measured: 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
The length of intensive care unit (ICU) stay (days)
Measured: Perioperative period (Hospital stay duration)
hospital stay
total length of hospital stay (days)
Measured: Perioperative period (Hospital Stay duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label, parallel, prospective, randomized study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- El-Sahel Teaching Hospital, National Hepatology & Tropical Medicine Research Institute
- Responsible party
- Principal investigator, Aya Mohammed Abdel Magid Abdel Hamid, Cairo University
- Investigators
- Mona A. Abdulmohsen, MD, Principal investigator, El-Sahel Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318766
- Sponsor's protocol ID
- HS000132
- Acronym
- LT
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohamed AA, AbdelMagid AM, Kamel AM, Mater MMI, AboEl-Magd GH, Sallam TA, Ahmeda A, Seddik MM, Abdel Aziz RS, Elgazzar NA, Sakr AA, Elagawy W, Abbas MH, Hamdy G, Ramdan A, Amin A, Abdulmohsen MA. Effect of Incentive Spirometer on Arterial Blood Gases in Liver Transplant Recipients. J Clin Exp Hepatol. 2026 Nov-Dec;16(6):103650. doi: 10.1016/j.jceh.2026.103650. Epub 2026 Aug 25.
PubMed 42774464
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incentive Spirometer on Arterial Blood Gases in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT07318766
- Acronym / sponsor ID
- LT / HS000132
- Conditions
- Liver Transplant Disorder
- Keywords
- Liver Transplant, Incentive Spirometer, Arterial Blood Gas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- El-Sahel Teaching Hospital, National Hepatology & Tropical Medicine Research Institute
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effect of adjunctive incentive spirometer on arterial blood gases (ABGs) and early postoperative recovery in liver transplant recipients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label, parallel, prospective, randomized study
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Incentive SpirometryPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive SpirometryAn 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. | Device | Incentive Spirometery plus standard exercises |
Primary outcome
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
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)
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)
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)
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, %).
2 secondary outcomes
length of intensive care unit (ICU) stay
Time frame: Perioperative period (Hospital stay duration)
hospital stay
Time frame: Perioperative period (Hospital Stay duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 42774464Mohamed AA, AbdelMagid AM, Kamel AM, Mater MMI, AboEl-Magd GH, Sallam TA, Ahmeda A, Seddik MM, Abdel Aziz RS, Elgazzar NA, Sakr AA, Elagawy W, Abbas MH, Hamdy G, Ramdan A, Amin A, Abdulmohsen MA. Effect of Incentive Spirometer on Arterial Blood Gases in Liver Transplant Recipients. J Clin Exp Hepatol. 2026 Nov-Dec;16(6):103650. doi: 10.1016/j.jceh.2026.103650. Epub 2026 Aug 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona A. Abdulmohsen, MD principal investigator
El-Sahel Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometry in people with Liver Transplant Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07318766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.