the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation.
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKasr El Aini Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Severe neurological impairment :Defined as GCS ≤8 or spinal cord injury above T5 .
Known hypersensitivity to doxapram.
Pregnancy or lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Doxapram
DrugDoxapram is used as a respiatory stimulant intended to enhance respiratory drive and diaphragmatic activity durig ventilator weaning.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervenous Doxapram During Weaning.Experimental treatment 1 intervention
Group B: Standard Weaning Care.No intervention 0 interventions
Trial outcomes
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
Successful liberation from mechanical ventilation without the need for reintubation or noninvasive ventilatory support.
Time frame
Within 48hr after extubation.Other outcomes
1
Duration of ICU Stay
Time frame
From ICU admission until ICU discharge, assessed up to 30 days.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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