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NCT Number: NCT07637149

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

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.

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Key information

Conditions

Mechanically Ventilated ICU Patients Diaphragm Excursion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxapram

Drug

Doxapram is used as a respiatory stimulant intended to enhance respiratory drive and diaphragmatic activity durig ventilator weaning.

Primary outcomes

  1. - 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.

Secondary outcomes

  1. Maximal Inspiratory Pressure(MIP)

    Time frame: Baseline and during weaning trial up to 120 minutes.

  2. Weaning Success Rate

    Time frame: Within 48hr after extubation.

    Successful liberation from mechanical ventilation without the need for reintubation or noninvasive ventilatory support.

Other outcomes

  1. Duration of ICU Stay

    Time frame: From ICU admission until ICU discharge, assessed up to 30 days.

Study contacts

Contact information is provided by the study sponsor or research team.

ahmed mekhemar Mekhemar, doctor

CONTACT

[email protected]

+201122296845

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation :a Randomized Double Blinded Study.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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