Mechanically Ventilated ICU PatientsPhase 4NCT07637149
the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation.
A Phase 4 study testing Doxapram in people with Mechanically Ventilated ICU Patients and Diaphragm Excursion, run by Kasr El Aini Hospital.
Trial summary
The goal of this clincal trial is to learn if doxapram is effective in weaning in adults on mechanical ventilation. The objectives of this study: Evaluate the effect of doxapram on diaphragmatic function (assessed by DE)during weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated ICU Patients, Diaphragm Excursion
- What is being tested?
- Doxapram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jan 2027
- Phase
- Phase 4
- 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
Who may be able to join
- Adults (≥18 years) on mechanical ventilation for >48 hours.
- Deemed ready for weaning by the clinical team: Defined as RSBI <105, P/F ratio >200, hemodynamic stability.
- Stable hemodynamics and adequate oxygenation (PaO₂/FiO₂ >150)
Who cannot join
- Severe neurological impairment :Defined as GCS ≤8 or spinal cord injury above T5 .
- Known hypersensitivity to doxapram.
- Pregnancy or lactation.
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
Official title: the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation :a Randomized Double Blinded Study.
The goal of this clincal trial is to learn if doxapram is effective in weaning in adults on mechanical ventilation.
The objectives of this study:
Read more
- Evaluate the effect of doxapram on diaphragmatic function (assessed by DE)during weaning from mechanical ventilation.
- Assess the impact of doxapram on respiratory muscle sterngth.
- Mointor adverse effects associated with doxapram administration.
Researchers will compare expermental group(intervenous doxapram during weaning)with control group(saline infusion)during weaning.
The patients who fulfull criteria of weaning will be subjected to our clincal trial and put on spontanous breathing trial for 120mins using positive end expiratory pressure (peep)5 cmh2o,pressure support 5cm h2o and fio2 0.3.By the end of the SBTthe patient will be extubated if ventilator parameters and vital signs were maintained within 20%of baseline values.
The patients will be followed up after extubation and afailed weaning will be defined as the neeed for either invasive or non invasive ventilation for 72 after extubation or failed SBT.
- Being tested
- Doxapram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxapramDrug
Doxapram is used as a respiatory stimulant intended to enhance respiratory drive and diaphragmatic activity durig ventilator weaning.
| Study group | Role | What they receive |
|---|---|---|
| Intervenous Doxapram During Weaning. | Experimental | Patient in this arm will receive intervenous doxapram during weaning from mechanical ventilation in addition to standard weaning care.Diaphragmatic excursion and respiratory parameters will be assessed during weaning process. Receives: Drug: Doxapram |
| Standard Weaning Care. | No intervention | Paients in this arm will receive standard weaning care without intervenous doxapram infusion.Diaphragmatic excursion and respiratory parameters will be assesseed during the weaning process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Diaphragmatic excursion (DE) measured by ultrasound.
Measured: Baseline(immediately before initiation of weaning trial) ,and at 15 minutes,60 minutes,and 120 minutes after initiation of weaning trial.
Secondary outcomes (2)
Maximal Inspiratory Pressure(MIP)
Measured: Baseline and during weaning trial up to 120 minutes.
Weaning Success Rate
Successful liberation from mechanical ventilation without the need for reintubation or noninvasive ventilatory support.
Measured: Within 48hr after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mechanically Ventilated ICU PatientsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective,randomized,double blinded,placebo-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mekhemar ali omar, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637149
- Sponsor's protocol ID
- effect of doxapram in weaning.
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wu JQ, Wang YX, Su D, Shao TH, Ding XX, Sun T, Cui N, Yu ZB. EFFECTS OF LEVOSIMENDAN ON DIAPHRAGMATIC DYSFUNCTION IN PATIENTS WITH SEPSIS. Shock. 2024 Jul 1;62(1):63-68. doi: 10.1097/SHK.0000000000002372. Epub 2024 Apr 8.
PubMed 38661179Moser KM, Luchsinger PC, Adamson JS, McMahon SM, Schlueter DP, Spivack M, Weg JG. Respiratory stimulation with intravenous doxapram in respiratory failure. A double-blind co-operative study. N Engl J Med. 1973 Mar 1;288(9):427-31. doi: 10.1056/NEJM197303012880901. No abstract available.
PubMed 4567320Eltrabili HH, Hasanin AM, Soliman MS, Lotfy AM, Hamimy WI, Mukhtar AM. Evaluation of Diaphragmatic Ultrasound Indices as Predictors of Successful Liberation From Mechanical Ventilation in Subjects With Abdominal Sepsis. Respir Care. 2019 May;64(5):564-569. doi: 10.4187/respcare.06391. Epub 2019 Jan 22.
PubMed 30670667de Waal CG, Hutten GJ, Kraaijenga JV, de Jongh FH, van Kaam AH. Doxapram Treatment and Diaphragmatic Activity in Preterm Infants. Neonatology. 2019;115(1):85-88. doi: 10.1159/000493359. Epub 2018 Oct 23.
PubMed 30352445Roesthuis L, van der Hoeven H, Sinderby C, Frenzel T, Ottenheijm C, Brochard L, Doorduin J, Heunks L. Effects of levosimendan on respiratory muscle function in patients weaning from mechanical ventilation. Intensive Care Med. 2019 Oct;45(10):1372-1381. doi: 10.1007/s00134-019-05767-y. Epub 2019 Oct 1.
PubMed 31576436Roesthuis LH, van der Hoeven JG, van Hees HWH, Schellekens WM, Doorduin J, Heunks LMA. Recruitment pattern of the diaphragm and extradiaphragmatic inspiratory muscles in response to different levels of pressure support. Ann Intensive Care. 2020 May 29;10(1):67. doi: 10.1186/s13613-020-00684-6.
PubMed 32472272Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.
PubMed 33940248Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5.
PubMed 34748940Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
PubMed 11790214
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation :a Randomized Double Blinded Study.
- ClinicalTrials.gov ID
- NCT07637149
- Acronym / sponsor ID
- effect of doxapram in weaning.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 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 clincal trial is to learn if doxapram is effective in weaning in adults on mechanical ventilation.
The objectives of this study:
- Evaluate the effect of doxapram on diaphragmatic function (assessed by DE)during weaning from mechanical ventilation.
- Assess the impact of doxapram on respiratory muscle sterngth.
- Mointor adverse effects associated with doxapram administration.
Researchers will compare expermental group(intervenous doxapram during weaning)with control group(saline infusion)during weaning.
The patients who fulfull criteria of weaning will be subjected to our clincal trial and put on spontanous breathing trial for 120mins using positive end expiratory pressure (peep)5 cmh2o,pressure support 5cm h2o and fio2 0.3.By the end of the SBTthe patient will be extubated if ventilator parameters and vital signs were maintained within 20%of baseline values.
The patients will be followed up after extubation and afailed weaning will be defined as the neeed for either invasive or non invasive ventilation for 72 after extubation or failed SBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective,randomized,double blinded,placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervenous Doxapram During Weaning. | Experimental | Drug: DoxapramPatient in this arm will receive intervenous doxapram during weaning from mechanical ventilation in addition to standard weaning care.Diaphragmatic excursion and respiratory parameters will be assessed during weaning process. |
| Standard Weaning Care. | No intervention | –Paients in this arm will receive standard weaning care without intervenous doxapram infusion.Diaphragmatic excursion and respiratory parameters will be assesseed during the weaning process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) on mechanical ventilation for >48 hours.
- Deemed ready for weaning by the clinical team: Defined as RSBI <105, P/F ratio >200, hemodynamic stability.
- Stable hemodynamics and adequate oxygenation (PaO₂/FiO₂ >150)
Key exclusion criteria (3 listed)
- Severe neurological impairment :Defined as GCS ≤8 or spinal cord injury above T5 .
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 |
|---|---|---|
| DoxapramDoxapram is used as a respiatory stimulant intended to enhance respiratory drive and diaphragmatic activity durig ventilator weaning. | Drug | Intervenous Doxapram During Weaning. |
Primary outcome
- Diaphragmatic excursion (DE) measured by ultrasound.
Time frame: Baseline(immediately before initiation of weaning trial) ,and at 15 minutes,60 minutes,and 120 minutes after initiation of weaning trial.
2 secondary outcomes
Maximal Inspiratory Pressure(MIP)
Time frame: Baseline and during weaning trial up to 120 minutes.
Weaning Success Rate
Time frame: Within 48hr after extubation.
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 9 Jun 2026.
- Background: PubMed 38661179Wu JQ, Wang YX, Su D, Shao TH, Ding XX, Sun T, Cui N, Yu ZB. EFFECTS OF LEVOSIMENDAN ON DIAPHRAGMATIC DYSFUNCTION IN PATIENTS WITH SEPSIS. Shock. 2024 Jul 1;62(1):63-68. doi: 10.1097/SHK.0000000000002372. Epub 2024 Apr 8.
- Background: PubMed 4567320Moser KM, Luchsinger PC, Adamson JS, McMahon SM, Schlueter DP, Spivack M, Weg JG. Respiratory stimulation with intravenous doxapram in respiratory failure. A double-blind co-operative study. N Engl J Med. 1973 Mar 1;288(9):427-31. doi: 10.1056/NEJM197303012880901. No abstract available.
- Background: PubMed 30670667Eltrabili HH, Hasanin AM, Soliman MS, Lotfy AM, Hamimy WI, Mukhtar AM. Evaluation of Diaphragmatic Ultrasound Indices as Predictors of Successful Liberation From Mechanical Ventilation in Subjects With Abdominal Sepsis. Respir Care. 2019 May;64(5):564-569. doi: 10.4187/respcare.06391. Epub 2019 Jan 22.
- Background: PubMed 30352445de Waal CG, Hutten GJ, Kraaijenga JV, de Jongh FH, van Kaam AH. Doxapram Treatment and Diaphragmatic Activity in Preterm Infants. Neonatology. 2019;115(1):85-88. doi: 10.1159/000493359. Epub 2018 Oct 23.
- Background: PubMed 31576436Roesthuis L, van der Hoeven H, Sinderby C, Frenzel T, Ottenheijm C, Brochard L, Doorduin J, Heunks L. Effects of levosimendan on respiratory muscle function in patients weaning from mechanical ventilation. Intensive Care Med. 2019 Oct;45(10):1372-1381. doi: 10.1007/s00134-019-05767-y. Epub 2019 Oct 1.
- Background: PubMed 32472272Roesthuis LH, van der Hoeven JG, van Hees HWH, Schellekens WM, Doorduin J, Heunks LMA. Recruitment pattern of the diaphragm and extradiaphragmatic inspiratory muscles in response to different levels of pressure support. Ann Intensive Care. 2020 May 29;10(1):67. doi: 10.1186/s13613-020-00684-6.
- Background: PubMed 33940248Helmy MA, Magdy Milad L, Osman SH, Ali MA, Hasanin A. Diaphragmatic excursion: A possible key player for predicting successful weaning in patients with severe COVID-19. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100875. doi: 10.1016/j.accpm.2021.100875. Epub 2021 Apr 30. No abstract available.
- Background: PubMed 34748940Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5.
- Background: PubMed 11790214Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxapram in people with Mechanically Ventilated ICU Patients and Diaphragm Excursion, run by Kasr El Aini Hospital.
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 3 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 9 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ahmed mekhemar Mekhemar, doctor (+201122296845, totaldamned@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Diaphragmatic excursion (DE) measured by ultrasound. (time frame: Baseline(immediately before initiation of weaning trial) ,and at 15 minutes,60 minutes,and 120 minutes after initiation of weaning trial.). 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 NCT07637149, which also lists 9 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 9 Jun 2026.