Respiration FailurePOCUS in RFNCT07820267
Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock
An observational study of Respiration Failure and Diaphragmatic Dysfunction, run by Assiut University at 1 site in Egypt.
Trial summary
This prospective observational cohort study aims to evaluate the prognostic value of serial bedside ultrasound assessment of diaphragmatic function in adult patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration Failure, Diaphragmatic Dysfunction, Mechanical Ventilation
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Jun 2028
- How long will I take part?
- 5 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients 18 years old or more admitted to ICU with septic shock diagnosed according to the sepsis-3 criteria. Eligible patients will be prospectively enrolled after meeting the predefined inclusion and exclusion criteria and will undergo serial bedside point of care ultrasound assessment of diaphragmatic function during the first 72 hours of ICU admission.
Who may be able to join
- Age ≥ 18 years old.
- Patients with septic shock.
- Patients with ICU admission during study period.
- Expected ICU stay for at least 72 hours.
- Informed consent from the patient or legal guardian when required.
Who cannot join
- Age less than 18 years old.
- Pre-existing neuromuscular disorders affecting respiratory muscles.
- Known diaphragmatic paralysis or diaphragmatic palsy.
- Significant phrenic nerve injury.
- Cervical spinal cord injury.
- Advanced chronic neuromuscular disease.
Show all 12Show fewer
- Previous major thoracic or diaphragmatic surgery.
- Severe chest wall deformity.
- Conditions preventing adequate diaphragmatic ultrasound assessment.
- Pregnancy, if required by local ethical policy.
- Patients with limitations of care that preclude full respiratory support.
- Refusal of consent where consent is required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dynamic Point of Care Ultrasound (POCUS) Imaging Assessment of Diaphragmatic Function as a Predictor of Respiratory Failure and Clinical Outcomes in Patients With Septic Shock.
This prospective observational cohort study aims to evaluate the prognostic value of serial bedside ultrasound assessment of diaphragmatic function in adult patients with septic shock. Diaphragmatic excursion, thickness, and thickening fraction will be assessed using point of care ultrasound at baseline and serially during the first 72 hours of intensive care admission. Dynamic changes in these parameters will be analyzed in relation to the development of respiratory failure, need for invasive mechanical ventilation, duration of mechanical ventilation, weaning and extubation outcomes, length of ICU stay, and mortality. The study will determine whether dynamic diaphragmatic ultrasound assessment can provide an early, non-invasive predictor of respiratory failure and adverse clinical outcomes in patients with septic shock.
Read the detailed description
Septic shock remains a major cause of morbidity and mortality among critically ill patients. Respiratory failure is a frequent and serious complication, resulting from a combination of sepsis-induced lung injury, acute respiratory distress syndrome, respiratory muscle dysfunction, and sepsis-induced myopathy. The diaphragm is the principal muscle of respiration and may be significantly affected during sepsis. Systemic inflammation, altered microcirculation, mitochondrial dysfunction, electrolyte abnormalities, prolonged immobilization, sedation, and mechanical ventilation can contribute to diaphragmatic dysfunction. Such dysfunction may impair spontaneous breathing, increase the risk of respiratory failure, prolong mechanical ventilation, and contribute to unsuccessful weaning and adverse clinical outcomes. Point-of-care ultrasound (POCUS) provides a non-invasive, bedside, radiation-free method for assessing diaphragmatic structure and function. The most commonly used parameters include diaphragmatic excursion (DE), diaphragmatic thickness, and diaphragmatic thickening fraction (DTF). Most available studies have assessed diaphragmatic function at a single point in time, particularly during weaning from mechanical ventilation. However, limited evidence exists regarding the prognostic value of serial dynamic assessment of diaphragmatic function in patients with septic shock from the early stages of ICU admission.
Dynamic changes in diaphragmatic function may provide more clinically meaningful information than a single measurement. Therefore, serial POCUS assessment may help identify patients at high risk of respiratory failure and predict important clinical outcomes.
- Keywords
- POCUS, septic shock, respiratory failure, diaphragm
- Medical subject headings
- Respiratory Insufficiency, Shock, Septic
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 |
|---|---|---|
| Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment. | Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment. primary respiratory outcome: Development of respiratory failure requiring invasive mechanical ventilation within 7 days after enrollment. | |
| Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment. | Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment. outcomes: Duration of mechanical ventilation, weaning failure, extubation failure or reintubation, ICU and hospital mortality and ICU length of stay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
Number of participants who develop respiratory failure requiring initiation of invasive mechanical ventilation, assessed by clinical criteria and the requirement for endotracheal intubation and invasive mechanical ventilation.
Measured: From Baseline through Day 7
Diaphragmatic Excursion Measured by Point of Care ultrasound
Diaphragmatic Excursion measured using M mode point of care ultrasound during spontaneous breathing or ventilator supported breathing, as applicable and measured in millimeter. Three measurements will be obtained and averaged.
Measured: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic Thickness Measured by Point of Care Ultrasound
Diaphragmatic thickness measured at the zone of apposition using B mode point of care ultrasound at end expiration and measured in millimeter. Three measurements will be obtained and averaged.
Measured: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound
Diaphragmatic thickening fraction measured using point of care ultrasound and calculated as [(inspiratory thickness-expiratory thickness) / expiratory thickness] * 100 and measured in percentage. Three measurements will be obtained and averaged.
Measured: Baseline, 24 hours, 48 hours, and 72 hours
Secondary outcomes (6)
Time to Initiation of Invasive Mechanical Ventilation
Time from study enrollment to initiation of invasive mechanical ventilation, measured in hours
Measured: From baseline through Day 7
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation, calculated from the initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation, measured in days.
Measured: From initiation of invasive mechanical ventilation until successful discontinuation of invasive mechanical ventilation, assessed through ICU discharge or up to 28 days, whichever comes first.
Number of Participants with Weaning failure
Number of participants who fail the initial attempt to discontinue invasive mechanical ventilation according to predefined clinical criteria and subsequently require continuation or resumption of mechanical ventilatory support.
Measured: From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.
Number of Participants With Extubation failure
Number of participants requiring reintubation and reinstitution of invasive mechanical ventilation following planned extubation.
Measured: within 72 hours after extubation.
Duration of Intensive Care Unit stay
Duration of stay in the intensive care unit from ICU admission until ICU discharge, measured in days.
Measured: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
Number of Participants Who Die During Intensive Care Unit Stay
Number of participants who die during the Intensive Care Unit stay
Measured: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Respiration FailureStudies 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)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Gamal Abd El Hafeez Haridy, Assiut University
- Investigators
- Refaat Fathy Abdelaal, professor, Study director, Assiut UniversityDina Ali Ahmed, doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820267
- Sponsor's protocol ID
- POCUS in septic shock
- Acronym
- POCUS in RF
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682.
PubMed 31876624Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.
PubMed 28864053Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
PubMed 24949192Boussuges 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 19017880Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
PubMed 27620292Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
PubMed 23344830Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.
PubMed 28917004Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.
PubMed 26167730Powers SK, Wiggs MP, Sollanek KJ, Smuder AJ. Ventilator-induced diaphragm dysfunction: cause and effect. Am J Physiol Regul Integr Comp Physiol. 2013 Sep;305(5):R464-77. doi: 10.1152/ajpregu.00231.2013. Epub 2013 Jul 10.
PubMed 23842681Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
PubMed 23786764Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Callahan LA, Supinski GS. Sepsis-induced myopathy. Crit Care Med. 2009 Oct;37(10 Suppl):S354-67. doi: 10.1097/CCM.0b013e3181b6e439.
PubMed 20046121Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.
PubMed 29937192Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Point of Care Ultrasound (POCUS) Imaging Assessment of Diaphragmatic Function as a Predictor of Respiratory Failure and Clinical Outcomes in Patients With Septic Shock.
- ClinicalTrials.gov ID
- NCT07820267
- Acronym / sponsor ID
- POCUS in RF / POCUS in septic shock
- Keywords
- POCUS, septic shock, respiratory failure, diaphragm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Sep 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 prospective observational cohort study aims to evaluate the prognostic value of serial bedside ultrasound assessment of diaphragmatic function in adult patients with septic shock. Diaphragmatic excursion, thickness, and thickening fraction will be assessed using point of care ultrasound at baseline and serially during the first 72 hours of intensive care admission. Dynamic changes in these parameters will be analyzed in relation to the development of respiratory failure, need for invasive mechanical ventilation, duration of mechanical ventilation, weaning and extubation outcomes, length of ICU stay, and mortality. The study will determine whether dynamic diaphragmatic ultrasound assessment can provide an early, non-invasive predictor of respiratory failure and adverse clinical outcomes in patients with septic shock.
Detailed description
Septic shock remains a major cause of morbidity and mortality among critically ill patients. Respiratory failure is a frequent and serious complication, resulting from a combination of sepsis-induced lung injury, acute respiratory distress syndrome, respiratory muscle dysfunction, and sepsis-induced myopathy. The diaphragm is the principal muscle of respiration and may be significantly affected during sepsis. Systemic inflammation, altered microcirculation, mitochondrial dysfunction, electrolyte abnormalities, prolonged immobilization, sedation, and mechanical ventilation can contribute to diaphragmatic dysfunction. Such dysfunction may impair spontaneous breathing, increase the risk of respiratory failure, prolong mechanical ventilation, and contribute to unsuccessful weaning and adverse clinical outcomes. Point-of-care ultrasound (POCUS) provides a non-invasive, bedside, radiation-free method for assessing diaphragmatic structure and function. The most commonly used parameters include diaphragmatic excursion (DE), diaphragmatic thickness, and diaphragmatic thickening fraction (DTF). Most available studies have assessed diaphragmatic function at a single point in time, particularly during weaning from mechanical ventilation. However, limited evidence exists regarding the prognostic value of serial dynamic assessment of diaphragmatic function in patients with septic shock from the early stages of ICU admission.
Dynamic changes in diaphragmatic function may provide more clinically meaningful information than a single measurement. Therefore, serial POCUS assessment may help identify patients at high risk of respiratory failure and predict important clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment. | – | –Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment. primary respiratory outcome: Development of respiratory failure requiring invasive mechanical ventilation within 7 days after enrollment. |
| Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment. | – | –Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment. outcomes: Duration of mechanical ventilation, weaning failure, extubation failure or reintubation, ICU and hospital mortality and ICU length of stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients 18 years old or more admitted to ICU with septic shock diagnosed according to the sepsis-3 criteria. Eligible patients will be prospectively enrolled after meeting the predefined inclusion and exclusion criteria and will undergo serial bedside point of care ultrasound assessment of diaphragmatic function during the first 72 hours of ICU admission.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Patients with septic shock.
- Patients with ICU admission during study period.
- Expected ICU stay for at least 72 hours.
- Informed consent from the patient or legal guardian when required.
Key exclusion criteria (12 listed)
- Age less than 18 years old.
- Pre-existing neuromuscular disorders affecting respiratory muscles.
- Known diaphragmatic paralysis or diaphragmatic palsy.
- Significant phrenic nerve injury.
- Cervical spinal cord injury.
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
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
Time frame: From Baseline through Day 7
Number of participants who develop respiratory failure requiring initiation of invasive mechanical ventilation, assessed by clinical criteria and the requirement for endotracheal intubation and invasive mechanical ventilation.
Diaphragmatic Excursion Measured by Point of Care ultrasound
Time frame: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic Excursion measured using M mode point of care ultrasound during spontaneous breathing or ventilator supported breathing, as applicable and measured in millimeter. Three measurements will be obtained and averaged.
Diaphragmatic Thickness Measured by Point of Care Ultrasound
Time frame: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic thickness measured at the zone of apposition using B mode point of care ultrasound at end expiration and measured in millimeter. Three measurements will be obtained and averaged.
Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound
Time frame: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic thickening fraction measured using point of care ultrasound and calculated as [(inspiratory thickness-expiratory thickness) / expiratory thickness] * 100 and measured in percentage. Three measurements will be obtained and averaged.
6 secondary outcomes
Time to Initiation of Invasive Mechanical Ventilation
Time frame: From baseline through Day 7
Duration of invasive mechanical ventilation
Time frame: From initiation of invasive mechanical ventilation until successful discontinuation of invasive mechanical ventilation, assessed through ICU discharge or up to 28 days, whichever comes first.
Number of Participants with Weaning failure
Time frame: From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.
Number of Participants With Extubation failure
Time frame: within 72 hours after extubation.
Duration of Intensive Care Unit stay
Time frame: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
Number of Participants Who Die During Intensive Care Unit Stay
Time frame: From baseline (ICU admission) until ICU discharge or death, assessed up to 28 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 15 Sep 2026.
- Background: PubMed 31876624Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682.
- Background: PubMed 28864053Llamas-Alvarez AM, Tenza-Lozano EM, Latour-Perez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31.
- Background: PubMed 24949192Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
- Background: PubMed 19017880Boussuges 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.
- Background: PubMed 27620292Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
- Background: PubMed 23344830Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
- Background: PubMed 28917004Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.
- Background: PubMed 26167730Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.
- Background: PubMed 23842681Powers SK, Wiggs MP, Sollanek KJ, Smuder AJ. Ventilator-induced diaphragm dysfunction: cause and effect. Am J Physiol Regul Integr Comp Physiol. 2013 Sep;305(5):R464-77. doi: 10.1152/ajpregu.00231.2013. Epub 2013 Jul 10.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Background: PubMed 23786764Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- 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.
Refaat Fathy Abdelaal, professor study director
Assiut University
Dina Ali Ahmed, doctor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration Failure and Diaphragmatic Dysfunction, run by Assiut 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 5 inclusion and 12 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 15 Sep 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?
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 Abdallah Gamal Abd El Hafeez, Master (+0201221248314, abdallah.gamal0111@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation. (time frame: From Baseline through Day 7). The study lists 4 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 NCT07820267, which also lists 15 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 15 Sep 2026.