the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation.

June 5, 2026 updated by: ahmed mekhemar ali omar, Kasr El Aini Hospital

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:

  • 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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Severe neurological impairment :Defined as GCS ≤8 or spinal cord injury above T5 .

    • Known hypersensitivity to doxapram.
    • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervenous Doxapram During Weaning.
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.
Drug: Doxapram
Doxapram is used as a respiatory stimulant intended to enhance respiratory drive and diaphragmatic activity durig ventilator weaning.
No Intervention: Standard Weaning Care.
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- 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.
Baseline(immediately before initiation of weaning trial) ,and at 15 minutes,60 minutes,and 120 minutes after initiation of weaning trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Inspiratory Pressure(MIP)
Time Frame: Baseline and during weaning trial up to 120 minutes.
Baseline and during weaning trial up to 120 minutes.
Weaning Success Rate
Time Frame: Within 48hr after extubation.
Successful liberation from mechanical ventilation without the need for reintubation or noninvasive ventilatory support.
Within 48hr after extubation.

Other Outcome Measures

Outcome Measure
Time Frame
Duration of ICU Stay
Time Frame: From ICU admission until ICU discharge, assessed up to 30 days.
From ICU admission until ICU discharge, assessed up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • effect of doxapram in weaning.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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