The current disease known as COVID-19 has involved the whole world with patients developing inability to breath as the most severe complication requiring machine support of breathing. However, due to scarcity of such machines in kenya, a team at kenyatta University have developed a medical device called 'TIBA VENT' mechanical ventilator from locally available materials  to respond to the challenges. As part of requlatory requirements for registration, marketing and commercialization we are applying for approval to conduct clinical trial to verify that the device is as effective and safe as devices already in use. This shall involve connecting the device to patients with breathing problems in the hospital critical care unit and assessing its performance. As a safety measure, the already certified mechanical ventilators in the hospital will be on standby throughout. The information obtained will assist in refining the design and production processes of the new device before roll out for commercial use.

To determine safety and clinical performance of developed prototype ventilator alongside established ventilators and demonstrate evidence that the level of device effectiveness consistently and accurately meets requirements for the labelled application claimed.

1. Main Objective:-To Clinically validate the safety and efficacy of "KU TIBA VENT" among patients requiring PSV/SIMV in critical care unit during weaning  phase of ventilation
2. Secondary Objectives-To asses: (a) Adverse events associated with "Ku TIBA VENT" during the weaning phase of ventilation in patients with respiratory failure; (b) Mortality associated with "Ku TIBA VENT" during 24 Hours observation period
3. Exploratory Objectives:-(a) Evaluating patient comfort during ventilation with this device; (b) Assessing ease of use of this device for doctors and medical staff
4. Outcome measures and measurements:(a)Comparison of ventilator settings and actual output (gas flows, pressures, volumes) against KEBS standards; (b) Arterial blood gas analysis for O2, CO2, pH; (c) Number of adverse events of special interest such as barotrauma as seen on chest X-Ray; (d) Incidence of 24 hour mortality during  observation period; (e) perfomance of alarms and triggers and vitals signs such as heart rate, blood pressure; (f) Patient comfort on a 4 point scale; (g) Clinical user questionnaire responses

Study site: Kenyatta University Teaching and Research Hospital Critical Care Unit. This is 600 bed hospital located in Kiambu County along the Northern Bypass on the western part of Kenyatta University. The hospital is a tertiary level 6 facility specializing in oncology, infectious diseases, and all kinds of surgical procedures including transplants. It has twenty bed adult ICU having two wings, vs COVID-19 designated and non COVID-19 sections.

Study Population:

Patients admitted to Intensive care unit (ICU) requiring mechanically ventilation (endotracheal or tracheostomy) during weaning phase of ventilation

Eligibility

Criteria

Inclusion Criteria:

• Intubated and mechanically ventilated patients in the ICU
• Anticipated length of intubation at least 12 hours.
• The primary attending physician approves use of the protocol on the patient.
• Meets weaning criteria

Exclusion Criteria:

• ventilation for chronic illnesses
• No consent or consent refusal

Study methodology: After consent, the device will be connected to the patients. A software management tool for ventilator management will be placed at the bedside for each enrolled patient, and recommendations regarding changing ventilator support will be provided to the clinicians every several hours during  weaning phases. The patients will be randomized to either the KU TIBA VENT, or the usual standard ventilator in the unit. The duration of intervention will be 4 hours.  When ventilator support is below a threshold, recommendations will be made to perform spontaneous breathing trials. The clinicians will ultimately decide whether to accept or reject the recommendations, and will evaluate the patient before each potential change to the ventilator. The acceptance or rejection of recommendations will be tracked, and used to refine the intervention. A Fluke respiratory analyzer will be used to measure the ventilator performance. Arterial blood gases will be done at intervals, before, one hour after starting and on the fourth hour at th end. Chest X-Ray will be done to investigate for barotrauma.

 A functional and clinically validated mechanical ventilator normally in use in the unit will be available as alternative  set on standby mode as replacement at the shortest notice should the performance of the device under investigation be wanting. There will be a team of biomedical engineers who participated in the design and development (qualified plus the students) as a backup at short notice and on demand. In addition, the investigation medical team (qualified anaesthetist & critical specialist as well as the nursing plus corresponding medical students) shall be available for consultation, trouble shooting and training in the use of the device.

Follow up: Clinical outcomes will be followed while in the ICU including re-intubation, medications administered, and ICU length of stay. No follow up after ICU discharge is planned.

Analysis plans:The sample size will 30 patients, 15 in each arm. Data will be used to refine the design, test the acceptability of prototype recommendations to bedside providers, and  to apply for registration for commercial production.  These analyses will be descriptive.

Study site: Kenyatta University Teaching and Research Hospital Critical Care Unit. This is 600 bed hospital located in Kiambu County along the Northern Bypass on the western part of Kenyatta University. The hospital is a tertiary level 6 facility specializing in oncology, infectious diseases, and all kinds of surgical procedures including transplants. It has twenty bed adult ICU having two wings, vs COVID-19 designated and non COVID-19 sections.