Cirrhosis of the LiverNCT07667608
Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings
An observational study of Cirrhosis of the Liver and Ascites, run by Assiut University.
Trial summary
The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis of the Liver, Ascites, Pleural Effusion Disorder
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2026to 10 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (≥18 years of age) with confirmed diagnosis of liver cirrhosis attending the hepatology outpatient clinic or admitted to the hepatology inpatient unit of the study institution. Study Subgroups The total study sample will consist of 120 participants, including 95 patients with liver cirrhosis and 25 healthy controls. The cirrhotic cohort will include patients across different Child-Pugh classes and MELD scores and will encompass clinically relevant subgroups such as patients with ascites undergoing paracentesis, hepatic hydrothorax, and hepatocellular carcinoma (HCC). * Subgroup A: Ascites/Paracentesis (n=30): Patients with tense or refractory ascites for whom large-volume paracentesis is clinically indicated. This subgroup will contribute both cross-sectional and longitudinal (pre/post paracentesis) data. * Subgroup B: Hepatic Hydrothorax (n=40): Twenty patients with confirmed hepatic hydrothorax (HH; defined as pleural effusion >500 mL in the absence of primary cardiopulm
Who may be able to join
- Age ≥18 years.
- Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.
- Ability to provide written informed consent in Arabic or English.
- For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.
- For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.
- For Subgroup C: radiologically confirmed HCC by triphasic CT or MRI according to EASL/AASLD diagnostic criteria, with available CT imaging for L3 SMI analysis.
Who cannot join
- Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1/FVC <70% with FEV1 <60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.
- Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.
- Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.
- Active mechanical ventilation at time of enrollment.
- Pregnancy.
- Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).
Show all 9Show fewer
- Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).
- Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.
- Refusal or inability to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are:
Do patients with cirrhosis show reduced diaphragmatic function compared to healthy adults?
Read more
Does removal of ascitic fluid by paracentesis improve diaphragmatic mechanics?
Can ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans?
Participants will:
Undergo diaphragmatic ultrasound during quiet and deep breathing
Provide clinical and laboratory data related to liver disease severity
In some cases, have ultrasound repeated before and after paracentesis
For patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass
Read the detailed description
This study is a prospective observational cohort designed to evaluate diaphragmatic structure and function in adults with liver cirrhosis. Using bedside ultrasound, the study will measure diaphragmatic thickness, thickening fraction, and excursion, and compare these values across different stages of liver disease severity and complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup of patients undergoing large-volume paracentesis will have ultrasound assessments before and after fluid removal to determine the acute impact of ascites drainage on diaphragmatic mechanics. In patients with hepatocellular carcinoma, existing CT scans will be analyzed to calculate skeletal muscle index, allowing correlation between ultrasound parameters and sarcopenia. Healthy volunteers will serve as a reference group for establishing normative values. Clinical and laboratory data, respiratory outcomes, and hospitalization details will also be collected to explore associations between diaphragmatic dysfunction and patient prognosis. The study aims to validate diaphragmatic ultrasound as a simple, non-invasive tool for respiratory monitoring and sarcopenia assessment in cirrhosis, particularly in resource-limited settings.
- Conditions
- Cirrhosis of the Liver, Ascites, Pleural Effusion Disorder, Hepatocellular Carcinoma (HCC), Sarcopenia, Diaphragm Movement
- Medical subject headings
- Fibrosis, Ascites, Pleural Effusion, Carcinoma, Hepatocellular, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Liver Cirrhosis | This cohort includes adults diagnosed with liver cirrhosis, with subgroups defined by complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup undergoing paracentesis will be assessed before and after fluid removal to evaluate acute changes in diaphragmatic function. In patients with hepatocellular carcinoma, CT scans will be analyzed to calculate skeletal muscle index for correlation with ultrasound findings. A small number of healthy volunteers will also undergo diaphragmatic ultrasound to establish normative reference values; however, they are not considered a separate cohort for analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm]
Diaphragmatic thickness at end-expiration (Tdi-exp) and end-inspiration (Tdi-insp) measured by B-mode ultrasound.
Measured: Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction (TF) [%]
Thickening fraction calculated as [(Tdi-insp - Tdi-exp) / Tdi-exp] × 100, measured by B-mode ultrasound.
Measured: Baseline (Day 1, at enrollment).
Diaphragmatic Excursion (DE) [cm]
Amplitude of diaphragmatic displacement measured by M-mode ultrasound during quiet breathing.
Measured: Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Thickness Across Cirrhosis Stages
Mean differences in diaphragmatic thickness (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.
Unit of Measure: Mean difference (cm).
Measured: Baseline (Day 1, at enrollment)
Group Differences in Diaphragmatic Thickening Fraction Across Cirrhosis Stages
Mean differences in diaphragmatic thickening fraction (%) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.
Unit of Measure: Mean difference (%).
Measured: Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Excursion Across Cirrhosis Stages
Mean differences in diaphragmatic excursion (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.
Unit of Measure: Mean difference (cm).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickness with Disease Severity
Correlation between diaphragmatic thickness (cm) and liver disease severity scores (Child-Pugh class, MELD score).
Unit of Measure: Correlation coefficient (r).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickening Fraction (TF) with Disease Severity
Correlation between diaphragmatic thickening fraction (%) and liver disease severity scores (Child-Pugh class, MELD score).
Unit of Measure: Correlation coefficient (r).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Excursion (DE) with Disease Severity
Correlation between diaphragmatic excursion (cm) and liver disease severity scores (Child-Pugh class, MELD score).
Unit of Measure: Correlation coefficient (r).
Measured: Baseline (Day 1, at enrollment).
Secondary outcomes (13)
Correlation between diaphragmatic ultrasound parameters and skeletal muscle index (CT scans)
In patients with hepatocellular carcinoma, triphasic CT scans will be analyzed to calculate skeletal muscle index. These values will be correlated with diaphragmatic ultrasound parameters to assess the utility of ultrasound as a surrogate marker of sarcopenia.
Measured: At baseline (single measurement)
Change in Diaphragmatic Thickness After Paracentesis
Change in diaphragmatic thickness (cm) measured by B-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis.
Unit of Measure: Mean difference (cm).
Measured: Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Thickening Fraction After Paracentesis
Change in diaphragmatic thickening fraction (%) measured by B-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis.
Unit of Measure: Mean difference (%).
Measured: Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Excursion After Paracentesis
Change in diaphragmatic excursion (cm) measured by M-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis.
Unit of Measure: Mean difference (cm).
Measured: Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Diaphragmatic Thickness in Patients With vs. Without Hepatic Hydrothorax
Comparison of mean diaphragmatic thickness (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.
Unit of Measure: Mean difference (cm).
Measured: Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction in Patients With vs. Without Hepatic Hydrothorax
Comparison of mean diaphragmatic thickening fraction (%) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.
Unit of Measure: Mean difference (%).
Measured: Baseline (Day 1, at enrollment).
Diaphragmatic Excursion in Patients With vs. Without Hepatic Hydrothorax
Comparison of mean diaphragmatic excursion (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.
Unit of Measure: Mean difference (cm).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Dyspnea Score
Correlation between diaphragmatic dysfunction (defined by ultrasound parameters) and dyspnea severity measured by the mMRC scale (0-4).
Unit of Measure: Correlation coefficient (r).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Respiratory Rate
Correlation between diaphragmatic dysfunction and respiratory rate (breaths/min).
Unit of Measure: Correlation coefficient (r).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Oxygen Saturation
Correlation between diaphragmatic dysfunction and peripheral oxygen saturation (SpO₂, %).
Unit of Measure: Correlation coefficient (r).
Measured: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Length of Hospital Stay
Correlation between diaphragmatic dysfunction (defined by ultrasound parameters: thickness, thickening fraction, excursion) and length of hospital stay (days). Unit of Measure: Correlation coefficient (r).
Measured: During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with ICU Admission
Correlation between diaphragmatic dysfunction and need for ICU admission. Unit of Measure: Odds ratio (% of patients requiring ICU admission).
Measured: During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with In-Hospital Complications
Correlation between diaphragmatic dysfunction and occurrence of complications (e.g., respiratory failure, infection). Unit of Measure: Incidence (% of patients with complications).
Measured: During hospitalization (up to 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis of the LiverStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Refaat Mohamed Abdelshafy Samasiri, Assiut University
- Investigators
- Ahmed Helmy Salem, professor, Principal investigator, Assiut UniversityMaiada Kamal Eldeen Hashem, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667608
- Sponsor's protocol ID
- DiaphragmCirrhosis_AU26
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013 Nov 26;4:863. doi: 10.3389/fpsyg.2013.00863.
PubMed 24324449Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
PubMed 27330520Haaksma ME, Smit JM, Boussuges A, Demoule A, Dres M, Ferrari G, Formenti P, Goligher EC, Heunks L, Lim EHT, Mokkink LB, Soilemezi E, Shi Z, Umbrello M, Vetrugno L, Vivier E, Xu L, Zambon M, Tuinman PR. EXpert consensus On Diaphragm UltraSonography in the critically ill (EXODUS): a Delphi consensus statement on the measurement of diaphragm ultrasound-derived parameters in a critical care setting. Crit Care. 2022 Apr 8;26(1):99. doi: 10.1186/s13054-022-03975-5.
PubMed 35395861Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):642-9. doi: 10.1007/s00134-015-3687-3. Epub 2015 Feb 19.
PubMed 25693448GBD 2017 Cirrhosis Collaborators. The global, regional, and national burden of cirrhosis by cause in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):245-266. doi: 10.1016/S2468-1253(19)30349-8. Epub 2020 Jan 22.
PubMed 31981519Ebadi M, Bhanji RA, Dunichand-Hoedl AR, Mazurak VC, Baracos VE, Montano-Loza AJ. Sarcopenia Severity Based on Computed Tomography Image Analysis in Patients with Cirrhosis. Nutrients. 2020 Nov 11;12(11):3463. doi: 10.3390/nu12113463.
PubMed 33187310D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J Hepatol. 2006 Jan;44(1):217-31. doi: 10.1016/j.jhep.2005.10.013. Epub 2005 Nov 9. No abstract available.
PubMed 16298014Carey EJ, Lai JC, Sonnenday C, Tapper EB, Tandon P, Duarte-Rojo A, Dunn MA, Tsien C, Kallwitz ER, Ng V, Dasarathy S, Kappus M, Bashir MR, Montano-Loza AJ. A North American Expert Opinion Statement on Sarcopenia in Liver Transplantation. Hepatology. 2019 Nov;70(5):1816-1829. doi: 10.1002/hep.30828. Epub 2019 Aug 19.
PubMed 31220351Cappellini I, Picciafuochi F, Bartolucci M, Matteini S, Virgili G, Adembri C. Evaluation of diaphragm thickening by diaphragm ultrasonography: a reproducibility and a repeatability study. J Ultrasound. 2021 Dec;24(4):411-416. doi: 10.1007/s40477-020-00462-x. Epub 2020 May 1.
PubMed 32358646Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
PubMed 19017880Boussuges A, Finance J, Chaumet G, Bregeon F. Diaphragmatic motion recorded by M-mode ultrasonography: limits of normality. ERJ Open Res. 2021 Mar 22;7(1):00714-2020. doi: 10.1183/23120541.00714-2020. eCollection 2021 Jan.
PubMed 33778044
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings
- ClinicalTrials.gov ID
- NCT07667608
- Acronym / sponsor ID
- DiaphragmCirrhosis_AU26
- Conditions
- Cirrhosis of the Liver, Ascites, Pleural Effusion Disorder, Hepatocellular Carcinoma (HCC), Sarcopenia, Diaphragm Movement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 25 Jun 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.
The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are:
Do patients with cirrhosis show reduced diaphragmatic function compared to healthy adults?
Does removal of ascitic fluid by paracentesis improve diaphragmatic mechanics?
Can ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans?
Participants will:
Undergo diaphragmatic ultrasound during quiet and deep breathing
Provide clinical and laboratory data related to liver disease severity
In some cases, have ultrasound repeated before and after paracentesis
For patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass
Detailed description
This study is a prospective observational cohort designed to evaluate diaphragmatic structure and function in adults with liver cirrhosis. Using bedside ultrasound, the study will measure diaphragmatic thickness, thickening fraction, and excursion, and compare these values across different stages of liver disease severity and complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup of patients undergoing large-volume paracentesis will have ultrasound assessments before and after fluid removal to determine the acute impact of ascites drainage on diaphragmatic mechanics. In patients with hepatocellular carcinoma, existing CT scans will be analyzed to calculate skeletal muscle index, allowing correlation between ultrasound parameters and sarcopenia. Healthy volunteers will serve as a reference group for establishing normative values. Clinical and laboratory data, respiratory outcomes, and hospitalization details will also be collected to explore associations between diaphragmatic dysfunction and patient prognosis. The study aims to validate diaphragmatic ultrasound as a simple, non-invasive tool for respiratory monitoring and sarcopenia assessment in cirrhosis, particularly in resource-limited settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Liver Cirrhosis | – | –This cohort includes adults diagnosed with liver cirrhosis, with subgroups defined by complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup undergoing paracentesis will be assessed before and after fluid removal to evaluate acute changes in diaphragmatic function. In patients with hepatocellular carcinoma, CT scans will be analyzed to calculate skeletal muscle index for correlation with ultrasound findings. A small number of healthy volunteers will also undergo diaphragmatic ultrasound to establish normative reference values; however, they are not considered a separate cohort for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years of age) with confirmed diagnosis of liver cirrhosis attending the hepatology outpatient clinic or admitted to the hepatology inpatient unit of the study institution. Study Subgroups The total study sample will consist of 120 participants, including 95 patients with liver cirrhosis and 25 healthy controls. The cirrhotic cohort will include patients across different Child-Pugh classes and MELD scores and will encompass clinically relevant subgroups such as patients with ascites undergoing paracentesis, hepatic hydrothorax, and hepatocellular carcinoma (HCC). * Subgroup A: Ascites/Paracentesis (n=30): Patients with tense or refractory ascites for whom large-volume paracentesis is clinically indicated. This subgroup will contribute both cross-sectional and longitudinal (pre/post paracentesis) data. * Subgroup B: Hepatic Hydrothorax (n=40): Twenty patients with confirmed hepatic hydrothorax (HH; defined as pleural effusion >500 mL in the absence of primary cardiopulm
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.
- Ability to provide written informed consent in Arabic or English.
- For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.
- For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.
Key exclusion criteria (9 listed)
- Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1/FVC <70% with FEV1 <60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.
- Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.
- Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.
- Active mechanical ventilation at time of enrollment.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm]
Time frame: Baseline (Day 1, at enrollment).
Diaphragmatic thickness at end-expiration (Tdi-exp) and end-inspiration (Tdi-insp) measured by B-mode ultrasound.
Diaphragmatic Thickening Fraction (TF) [%]
Time frame: Baseline (Day 1, at enrollment).
Thickening fraction calculated as [(Tdi-insp - Tdi-exp) / Tdi-exp] × 100, measured by B-mode ultrasound.
Diaphragmatic Excursion (DE) [cm]
Time frame: Baseline (Day 1, at enrollment).
Amplitude of diaphragmatic displacement measured by M-mode ultrasound during quiet breathing.
Group Differences in Diaphragmatic Thickness Across Cirrhosis Stages
Time frame: Baseline (Day 1, at enrollment)
Mean differences in diaphragmatic thickness (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata. Unit of Measure: Mean difference (cm).
Group Differences in Diaphragmatic Thickening Fraction Across Cirrhosis Stages
Time frame: Baseline (Day 1, at enrollment).
Mean differences in diaphragmatic thickening fraction (%) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata. Unit of Measure: Mean difference (%).
Group Differences in Diaphragmatic Excursion Across Cirrhosis Stages
Time frame: Baseline (Day 1, at enrollment).
Mean differences in diaphragmatic excursion (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata. Unit of Measure: Mean difference (cm).
Correlation of Diaphragmatic Thickness with Disease Severity
Time frame: Baseline (Day 1, at enrollment).
Correlation between diaphragmatic thickness (cm) and liver disease severity scores (Child-Pugh class, MELD score). Unit of Measure: Correlation coefficient (r).
Correlation of Diaphragmatic Thickening Fraction (TF) with Disease Severity
Time frame: Baseline (Day 1, at enrollment).
Correlation between diaphragmatic thickening fraction (%) and liver disease severity scores (Child-Pugh class, MELD score). Unit of Measure: Correlation coefficient (r).
Correlation of Diaphragmatic Excursion (DE) with Disease Severity
Time frame: Baseline (Day 1, at enrollment).
Correlation between diaphragmatic excursion (cm) and liver disease severity scores (Child-Pugh class, MELD score). Unit of Measure: Correlation coefficient (r).
13 secondary outcomes
Correlation between diaphragmatic ultrasound parameters and skeletal muscle index (CT scans)
Time frame: At baseline (single measurement)
Change in Diaphragmatic Thickness After Paracentesis
Time frame: Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Thickening Fraction After Paracentesis
Time frame: Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Excursion After Paracentesis
Time frame: Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Diaphragmatic Thickness in Patients With vs. Without Hepatic Hydrothorax
Time frame: Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction in Patients With vs. Without Hepatic Hydrothorax
Time frame: Baseline (Day 1, at enrollment).
Diaphragmatic Excursion in Patients With vs. Without Hepatic Hydrothorax
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Dyspnea Score
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Respiratory Rate
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Oxygen Saturation
Time frame: Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Length of Hospital Stay
Time frame: During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with ICU Admission
Time frame: During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with In-Hospital Complications
Time frame: During hospitalization (up to 30 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 24324449Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013 Nov 26;4:863. doi: 10.3389/fpsyg.2013.00863.
- Background: PubMed 27330520Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
- Background: PubMed 35395861Haaksma ME, Smit JM, Boussuges A, Demoule A, Dres M, Ferrari G, Formenti P, Goligher EC, Heunks L, Lim EHT, Mokkink LB, Soilemezi E, Shi Z, Umbrello M, Vetrugno L, Vivier E, Xu L, Zambon M, Tuinman PR. EXpert consensus On Diaphragm UltraSonography in the critically ill (EXODUS): a Delphi consensus statement on the measurement of diaphragm ultrasound-derived parameters in a critical care setting. Crit Care. 2022 Apr 8;26(1):99. doi: 10.1186/s13054-022-03975-5.
- Background: PubMed 25693448Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):642-9. doi: 10.1007/s00134-015-3687-3. Epub 2015 Feb 19.
- Background: PubMed 31981519GBD 2017 Cirrhosis Collaborators. The global, regional, and national burden of cirrhosis by cause in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):245-266. doi: 10.1016/S2468-1253(19)30349-8. Epub 2020 Jan 22.
- Background: PubMed 33187310Ebadi M, Bhanji RA, Dunichand-Hoedl AR, Mazurak VC, Baracos VE, Montano-Loza AJ. Sarcopenia Severity Based on Computed Tomography Image Analysis in Patients with Cirrhosis. Nutrients. 2020 Nov 11;12(11):3463. doi: 10.3390/nu12113463.
- Background: PubMed 16298014D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J Hepatol. 2006 Jan;44(1):217-31. doi: 10.1016/j.jhep.2005.10.013. Epub 2005 Nov 9. No abstract available.
- Background: PubMed 31220351Carey EJ, Lai JC, Sonnenday C, Tapper EB, Tandon P, Duarte-Rojo A, Dunn MA, Tsien C, Kallwitz ER, Ng V, Dasarathy S, Kappus M, Bashir MR, Montano-Loza AJ. A North American Expert Opinion Statement on Sarcopenia in Liver Transplantation. Hepatology. 2019 Nov;70(5):1816-1829. doi: 10.1002/hep.30828. Epub 2019 Aug 19.
- Background: PubMed 32358646Cappellini I, Picciafuochi F, Bartolucci M, Matteini S, Virgili G, Adembri C. Evaluation of diaphragm thickening by diaphragm ultrasonography: a reproducibility and a repeatability study. J Ultrasound. 2021 Dec;24(4):411-416. doi: 10.1007/s40477-020-00462-x. Epub 2020 May 1.
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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.
Ahmed Helmy Salem, professor principal investigator
Assiut University
Maiada Kamal Eldeen Hashem principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis of the Liver and Ascites, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada Refaat Mohamed, MD (+201019860918, nadarefaat411@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm] (time frame: Baseline (Day 1, at enrollment).). The study lists 9 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 NCT07667608, which also lists 11 linked publications.
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 25 Jun 2026.