COPDNCT07022704
Doxapram Administration on Diaphragmatic Excursion in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease Undergoing Spontaneous Breathing Trial
An observational study of COPD and Mechanical Ventilation, run by Cairo University at 1 site in Egypt.
Trial summary
Researchers aim to evaluate the impact of doxapram administration on diaphragmatic excursion in chronic obstructive pulmonary disease (COPD) patients undergoing spontaneous breathing trial Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- COPD, Mechanical Ventilation, Weaning From Mechanical Ventilation
- What is being tested?
- Doxapram
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2025to 1 Nov 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic obstructive pulmonary diseases undergoing breathing trial
Who may be able to join
- Patients with moderate to severe chronic obstructive pulmonary disease undergoing spontaneous breathing trial
Who cannot join
- Refusal Allergy to doxapram neuromuscular disorders inability to evaluate the diaphragm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Cairo Governorate, 6890
Cairo University, 01007174836, kasralainirec@gmail.com
About this study
Official title: The Influence of Doxapram Administration on Diaphragmatic Excursion in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease Undergoing Spontaneous Breathing Trial: a Prospective Observational Study
Researchers aim to evaluate the impact of doxapram administration on diaphragmatic excursion in chronic obstructive pulmonary disease (COPD) patients undergoing spontaneous breathing trial
Read the detailed description
doxapram will be administered intravenously (IV) during spontaneous breathing trial. diaphragmatic excursion will be evaluated by an expert in respiratory muscle ultrasound
- Being tested
- Doxapram
- Keywords
- COPD, Doxapram, Diaphragmatic excursion
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxapramDrug
Doxapram will be given as 1.5 mg/kg will be given 10 minutes after the initiation of SBT
| Study group | Role | What they receive |
|---|---|---|
| Doxapram | All patients will receive doxapram during spontaneous breathing trial Receives: Drug: Doxapram |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Diaphragmatic excursion in mm
Measured: before and 10 minutes after doxappram
Secondary outcomes (2)
Arterial blood gases
Measured: before and 10 minutes after doxapram
Respiratory rate
Measured: before and 10 minutes after doxapram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start22 Jun 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022704
- Sponsor's protocol ID
- Doxapram in COPD
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data regarding this research will be available from the corresponding author upon reasonable request
Publications
Helmy 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 33940248Pourriat JL, Baud M, Lamberto C, Fosse JP, Cupa M. Effects of doxapram on hypercapnic response during weaning from mechanical ventilation in COPD patients. Chest. 1992 Jun;101(6):1639-43. doi: 10.1378/chest.101.6.1639.
PubMed 1600786Oikawa S, Nomura H, Nishio M, Nagata R, Hata T. Doxapram hydrochloride aggravates adrenaline-induced arrhythmias accompanied by bidirectional ventricular tachycardia. ISRN Cardiol. 2014 Jan 9;2014:212045. doi: 10.1155/2014/212045. eCollection 2014.
PubMed 24527224Rutka M, Palac M, Linek P. Diaphragmatic Mobility Loss in Subjects With Moderate to Very Severe COPD May Improve After In-Patient Pulmonary Rehabilitation. Respir Care. 2021 Feb;66(2):354. doi: 10.4187/respcare.08687. No abstract available.
PubMed 33514664Scheibe N, Sosnowski N, Pinkhasik A, Vonderbank S, Bastian A. Sonographic evaluation of diaphragmatic dysfunction in COPD patients. Int J Chron Obstruct Pulmon Dis. 2015 Sep 11;10:1925-30. doi: 10.2147/COPD.S85659. eCollection 2015.
PubMed 26392767
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Doxapram Administration on Diaphragmatic Excursion in Mechanically Ventilated Patients With Chronic Obstructive Pulmonary Disease Undergoing Spontaneous Breathing Trial: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07022704
- Acronym / sponsor ID
- Doxapram in COPD
- Keywords
- COPD, Doxapram, Diaphragmatic excursion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jun 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 15 Jun 2025 (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.
Researchers aim to evaluate the impact of doxapram administration on diaphragmatic excursion in chronic obstructive pulmonary disease (COPD) patients undergoing spontaneous breathing trial
Detailed description
doxapram will be administered intravenously (IV) during spontaneous breathing trial. diaphragmatic excursion will be evaluated by an expert in respiratory muscle ultrasound
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxapram | – | Drug: DoxapramAll patients will receive doxapram during spontaneous breathing trial |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic obstructive pulmonary diseases undergoing breathing trial
Key inclusion criteria (1 listed)
- Patients with moderate to severe chronic obstructive pulmonary disease undergoing spontaneous breathing trial
Key exclusion criteria (1 listed)
- Refusal Allergy to doxapram neuromuscular disorders inability to evaluate the diaphragm
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 will be given as 1.5 mg/kg will be given 10 minutes after the initiation of SBT | Drug | Doxapram |
Primary outcome
• Diaphragmatic excursion in mm
Time frame: before and 10 minutes after doxappram
2 secondary outcomes
Arterial blood gases
Time frame: before and 10 minutes after doxapram
Respiratory rate
Time frame: before and 10 minutes after doxapram
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 26 Jun 2025.
- Results publication: 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.
- Results publication: PubMed 1600786Pourriat JL, Baud M, Lamberto C, Fosse JP, Cupa M. Effects of doxapram on hypercapnic response during weaning from mechanical ventilation in COPD patients. Chest. 1992 Jun;101(6):1639-43. doi: 10.1378/chest.101.6.1639.
- Results publication: PubMed 24527224Oikawa S, Nomura H, Nishio M, Nagata R, Hata T. Doxapram hydrochloride aggravates adrenaline-induced arrhythmias accompanied by bidirectional ventricular tachycardia. ISRN Cardiol. 2014 Jan 9;2014:212045. doi: 10.1155/2014/212045. eCollection 2014.
- Results publication: PubMed 33514664Rutka M, Palac M, Linek P. Diaphragmatic Mobility Loss in Subjects With Moderate to Very Severe COPD May Improve After In-Patient Pulmonary Rehabilitation. Respir Care. 2021 Feb;66(2):354. doi: 10.4187/respcare.08687. No abstract available.
- Results publication: PubMed 26392767Scheibe N, Sosnowski N, Pinkhasik A, Vonderbank S, Bastian A. Sonographic evaluation of diaphragmatic dysfunction in COPD patients. Int J Chron Obstruct Pulmon Dis. 2015 Sep 11;10:1925-30. doi: 10.2147/COPD.S85659. eCollection 2015.
- Individual participant dataSharing planned: Undecided. Data regarding this research will be available from the corresponding author upon reasonable request
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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.
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 COPD and Mechanical Ventilation, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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 Mina Helmy, MD (+201007174836, dr_mina20002010@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Diaphragmatic excursion in mm (time frame: before and 10 minutes after doxappram). 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 NCT07022704, which also lists 5 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 26 Jun 2025.