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

NCT07637149 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: effect of doxapram in weaning.
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mechanically Ventilated ICU Patients; Diaphragm Excursion

Outcome Measures

Primary Outcomes (1)

• - Diaphragmatic excursion (DE) measured by ultrasound.

  Baseline(immediately before initiation of weaning trial) ,and at 15 minutes,60 minutes,and 120 minutes after initiation of weaning trial.

Secondary Outcomes (2)

• Maximal Inspiratory Pressure(MIP)

  Baseline and during weaning trial up to 120 minutes.

• Weaning Success Rate

  Within 48hr after extubation.

Other Outcomes (1)

• Duration of ICU Stay

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

Study Arms (2)

Intervenous Doxapram During Weaning.

EXPERIMENTAL

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

Standard Weaning Care.

NO INTERVENTION

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.

Interventions

Doxapram DRUG

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

Intervenous Doxapram During Weaning.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe neurological impairment :Defined as GCS ≤8 or spinal cord injury above T5 .
• Known hypersensitivity to doxapram.
• Pregnancy or lactation.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Related Publications (9)

• Wu JQ, Wang YX, Su D, Shao TH, Ding XX, Sun T, Cui N, Yu ZB. EFFECTS OF LEVOSIMENDAN ON DIAPHRAGMATIC DYSFUNCTION IN PATIENTS WITH SEPSIS. Shock. 2024 Jul 1;62(1):63-68. doi: 10.1097/SHK.0000000000002372. Epub 2024 Apr 8.

  PMID: 38661179 BACKGROUND

• Moser KM, Luchsinger PC, Adamson JS, McMahon SM, Schlueter DP, Spivack M, Weg JG. Respiratory stimulation with intravenous doxapram in respiratory failure. A double-blind co-operative study. N Engl J Med. 1973 Mar 1;288(9):427-31. doi: 10.1056/NEJM197303012880901. No abstract available.

  PMID: 4567320 BACKGROUND

• Eltrabili HH, Hasanin AM, Soliman MS, Lotfy AM, Hamimy WI, Mukhtar AM. Evaluation of Diaphragmatic Ultrasound Indices as Predictors of Successful Liberation From Mechanical Ventilation in Subjects With Abdominal Sepsis. Respir Care. 2019 May;64(5):564-569. doi: 10.4187/respcare.06391. Epub 2019 Jan 22.

  PMID: 30670667 BACKGROUND

• de Waal CG, Hutten GJ, Kraaijenga JV, de Jongh FH, van Kaam AH. Doxapram Treatment and Diaphragmatic Activity in Preterm Infants. Neonatology. 2019;115(1):85-88. doi: 10.1159/000493359. Epub 2018 Oct 23.

  PMID: 30352445 BACKGROUND

• Roesthuis L, van der Hoeven H, Sinderby C, Frenzel T, Ottenheijm C, Brochard L, Doorduin J, Heunks L. Effects of levosimendan on respiratory muscle function in patients weaning from mechanical ventilation. Intensive Care Med. 2019 Oct;45(10):1372-1381. doi: 10.1007/s00134-019-05767-y. Epub 2019 Oct 1.

  PMID: 31576436 BACKGROUND

• Roesthuis LH, van der Hoeven JG, van Hees HWH, Schellekens WM, Doorduin J, Heunks LMA. Recruitment pattern of the diaphragm and extradiaphragmatic inspiratory muscles in response to different levels of pressure support. Ann Intensive Care. 2020 May 29;10(1):67. doi: 10.1186/s13613-020-00684-6.

  PMID: 32472272 BACKGROUND

• 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.

  PMID: 33940248 BACKGROUND

• Adolf Helmy M, Magdy Milad L, Hasanin A, Mostafa M. The novel use of diaphragmatic excursion on hospital admission to predict the need for ventilatory support in patients with coronavirus disease 2019. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100976. doi: 10.1016/j.accpm.2021.100976. Epub 2021 Nov 5.

  PMID: 34748940 BACKGROUND

• Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

  PMID: 11790214 BACKGROUND

MeSH Terms

Interventions

Doxapram

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

ahmed mekhemar Mekhemar, doctor

CONTACT

+201122296845; totaldamned@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Candidate,Department of Anethesiology,Cairo University

Model Details: prospective,randomized,double blinded,placebo-controlled trial.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share