Health Condition 1: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
Intervention1: Artificial Breathing Capability Device (ABCD): The â??Artificial Breathing Capability Deviceâ?? (ABCD) is an electro-mechanical device designed as a cost-effective alternative to manual
and releasing the bag causes the bag to self-inflate and then be ready for the next compression.
Ventilation using manual compression of Ambu bag is essentially an uncontrolled procedure. It requires
Sponsors
Department of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: Any patient admitted with respiratory failure deemed by the treating team to require manual ventilation with Ambu bag (because of non-availability of a ventilator), for any clinical condition including respiratory failure due to respiratory diseases, neurologic diseases, intoxication or poisoning.
Exclusion criteria
Exclusion criteria: Patients on a mechanical ventilator. patient undergoing procedures such as resuscitation attempts, surgery, or other life-saving procedures. Patients deemed to be unsuitable for manual ventilation (for any reason) by the treating team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| o Clinical recovery and/or improvement: This will be defined as recovery from, or improvement in, the clinical condition necessitating hospitalization as determined by the treating team of physicians.Timepoint: o This will be assessed every three minutes until clinical recovery, transfer to ICU (for mechanical ventilation), death, or leaving against medical advice (LAMA) | — |
Secondary
| Measure | Time frame |
|---|---|
| o Health-care provider satisfaction.Timepoint: At end of therapy;o Health-care recipient satisfaction:Timepoint: At end of therapy;o Comparison of outcomes of interest between patients with primary respiratory disease (i.e lungs affected by the primary disease for example pneumonia, aspiration, acute respiratory distress syndrome, etc) versus those with primary non-respiratory disease (i.e lungs unaffected by the primary disease for example neurological illness, neuro-muscular weakness, poisoning affecting respiratory drive, drug overdosage, etc).Timepoint: At end of therapy;o Device failure: Any malfunction of the device and/or inability to operate in the clinical environment and or unanticipated effect associated with the device.Timepoint: This will be assessed every three minutes for the first six hours, every two minutes during the next 6 hours, and every 15 minutes thereafter, until clinical recovery, transfer to ICU (for mechanical ventilation), death, or leaving against medical advice (LAMA).;o Duration of ventilation: Duration in hours between initiation of ABCD ventilation (or manual ventilation) and cessation of ABCD ventilation (or manual ventilation) due to attainment of clinical end point and/or occurrence of any event deemed by the treating team to be (i) of unclear cause, or (ii) ABCD related, or (iii) ventilation related.Timepoint: o This will be assessed every three minutes until clinical recovery, transfer to ICU (for mechanical ventilation), death, or leaving against medical advice (LAMA);o Failure of ventilation: Defined as the absence of clinically meaningful chest rise and/or absence of auscultable air entry, and/or occurrence of any complication deemed to be related to ineffective ventilation by the treating team of physicians.Timepoint: This will be assessed every three minutes for the first six hours, every two minutes during the next 6 hours, and every 15 minutes thereafter, until clinical recovery, transfer to ICU (for mechanical ventilati | — |
Countries
India
Contacts
Public ContactProf Joseph L Mathew
Postgraduate Institute of Medical Education and Research
Outcome results
None listed