Status:
SUSPENDED
Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Christian Medical College and Hospital, Ludhiana, India
Ministry of Health, Ghana
Conditions:
Pulmonary Complications in Surgical Patients
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to reduce pulmonary complications in adult patients undergoing abdominal or thoracic surgery in COVID-19 exposed hospital environments. A Trial in Low and Middle Income Countr...
Detailed Description
This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new ...
Eligibility Criteria
Inclusion
- Patients aged 18 years and over. (This criteria MUST be made country-specific)
- Planned to undergo abdominal or thoracic elective or emergency inpatient surgery requiring general anaesthesia.
- Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms (to be monitored post-surgery for symptoms)
- Informed patient consent.
- Able to operate a vibrating mesh nebuliser, as assessed by the recruiting physician
Exclusion
- Procedures under local anaesthesia
- Known history of adverse reaction/contraindication to trial drug
- Pregnancy and/or lactating patients (including patients undergoing caesarean section)
- History of methaemoglobinaemia
- Patients receiving any type of prescribed nitric oxide-donating agents (e.g. Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)
- Unable to tolerate use of a nebuliser and/or deemed unlikely to be able to adhere to protocol in view of investigator
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
6400 Patients enrolled
Trial Details
Trial ID
NCT04386070
Start Date
May 16 2022
End Date
March 1 2027
Last Update
February 20 2025
Active Locations (9)
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1
University Of Abuja Teaching Hospital (Spoke)
Gwagwalada, Nigeria, 902101
2
Lagos University Teaching Hospital (Hub)
Lagos, Nigeria
3
Nnamdi Azikiwe University Teaching Hospital (Spoke)
Nnewi, Nigeria, 435101
4
University Teaching Hospital of Butare (CHUB) (Spoke)
Butare, Rwanda