Doxapram Administration on Diaphragmatic Excursion in Mec... | NCT07022704

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2025Estimated

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Nov 1, 2025Estimated

First Submitted Date

Jun 7, 2025

First Submission Date that Met QC Criteria

Jun 7, 2025

First Posted Date

Jun 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2025

Last Update Posted Date

Jun 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doxapram		All patients will receive doxapram during spontaneous breathing trial	Drug: Doxapram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxapram	Drug	Doxapram will be given as 1.5 mg/kg will be given 10 minutes after the initiation of SBT	Doxapram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Diaphragmatic excursion in mm		before and 10 minutes after doxappram

Secondary Outcomes

Measure	Description	Time Frame
Arterial blood gases		before and 10 minutes after doxapram
Respiratory rate		before and 10 minutes after doxapram

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with moderate to severe chronic obstructive pulmonary disease undergoing spontaneous breathing trial

Exclusion Criteria:

Refusal Allergy to doxapram neuromuscular disorders inability to evaluate the diaphragm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic obstructive pulmonary diseases undergoing breathing trial

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mina Helmy, MD	Contact	+201007174836		dr_mina20002010@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University	Recruiting	Cairo	Cairo Governorate	6890	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33940248	Result	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.
1600786	Result

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011760	Pyrrolidinones
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds