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A study to find the capability&safety of a new device named AnaConDA by giving sleep inducing medication to operated adult patients who require mechanical ventilation (artificial breathing through machine)

Feasibility and Safety of the AnaConDa device to deliver Isoflurane sedation to the elective postoperative mechanically ventilated patients: A prospective open label trial (INSTINCT I Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024437
Enrollment
50
Registered
2020-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R00-R09- Symptoms and signs involving the circulatory and respiratory systems

Interventions

Intervention1: Inhalational isoflurane via the AnaConDa™: After connecting the patients the ICU ventilators, and starting an intravenous Fentanyl infusion (0.5-15 microgram/kg/min) for analgesia, pati

Sponsors

Dept of Anaesthesia Critical Care and Pain Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 50-80 years 2. Weight 50-120 kg 3. Elective post-operative patients anticipated to require sedation between 12 -24 for elective mechanical ventilation. 4. Hemodynamically stable patients (not requiring more than 0.3 microgram/kg/min of noradrenaline) 5. Patients willing to participate in the trial by giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Contraindications to use of HME filter during mechanical ventilation, these may include, but not limited to: excessive secretions or pulmonary hemorrhage likely to block the filter, indications for reducing apparatus dead space. 2. Head trauma and neurosurgical patients or mental obtundation due to any other reason preoperatively. 3. Patients with raised ICP. 4. Low GCS ( 5. Pregnant or breast feeding women. 6. Family or personal history of malignant hyperthermia. 7. Patients already receiving sedation for more than >6 hours.

Design outcomes

Primary

MeasureTime frame
Proportion of time spent between Richmond Agitation Sedation Scale scores of either -3 or -4.Timepoint: Any time till the patient is planned for extubation

Secondary

MeasureTime frame
1. Incidence of post-operative delirium as measured by Confusion Assessment Method(CAM-ICU)Timepoint: At any point during the course of sedation if the RASS score is not between -3 or -4;2. Ease of administration (incidence of and proportion of difficulties in managing the equipment for administration overall and per patient)Timepoint: At the time when the patient is planned for extubation or at the end of 24 hours;3. Incidence of renal, hepatic, hemodynamic and other adverse effects and others, if anyTimepoint: Any time till discharge

Countries

India

Contacts

Public ContactDr Atul Kulkarni

Tata Memorial Centre

kaivalyaak@yahoo.co.in9869077526

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026