To compare the effects of a conventional and an advanced mode of ventilator on surgical patients admitted in ICU

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/05/033595
• Lead Sponsor: Director Principal Government Medical College and Hospital Chandigarh

Brief Summary

Mechanical ventilation involves close interactions between differentvariables such as pressure, flow, volume and time for optimal gas exchange. Conventionalventilators have inability to adjust ventilation according to the patient’svariables. Newer modes of ventilators circumvent the aforesaid drawback bymaking automatic adjustments according to the patient’s mechanical and ventilatory parameters. Pressure-regulatedvolume control (PRVC) mode is one of the newer advance mode of ventilationwhich integrates volume and pressure control ventilation. On search of literature, there are noexisting studies comparing the effect of PRVC mode with conventional mode ofventilation such as synchronizedintermittent mandatory ventilation-volume control (SIMV), specifically in post-exploratorylaparotomy patients requiring mechanical ventilatory support. The aim of the present randomized prospective double blindedstudy is to compare the ventilatory andcardiopulmonary variables in post exploratory laparotomy patients admitted tointensive care unit.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Last Update Posted: 2021-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 1.Patients on invasive mechanical ventilation and admitted in ICU following exploratory laparotomy due to ARF for less than 24 hours 2.Age group 18-60 years 3.Stable hemodynamic parameters (Mean Arterial Pressure between 70 mm Hg.
• 100 mm Hg, Heart Rate between 60.
• 100/minute, SPO2 ≥ 90%) 4.Richmond Agitation–Sedation Scale (RASS)between 0 and -2.

Exclusion Criteria

• 1.Refusal of informed consent 2.Pregnant women 3.Morbidly obese patients (BMI>35) 4.Patients diagnosed with ARDS (Mild, Moderate or Severe) according to Berlin’s definition.
• 5.Patients with severe or chronic heart, lung, hepatic or renal disease 6.Patients with severe neuromuscular disorders 7.Patients on vasopressors, cardiac depressants or neuromuscular blockers 8.Patients with traumatic brain injury 9.Patients with blunt or traumatic chest injury 10.Patients with severe multiple organ dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilatory Parameters ( Peak airway pressure, Platue pressure, Mean airway pressure, Mean airway pressure, Compliance, Static compliance, Airway resistance)	T1-Two hours after keeping on A/C VC mode just before switching to study mode (as per group allocation). | T2-Four hours after switching on study mode | T3-Twelve hours after switching on study mode

Secondary Outcome Measures

Name	Time	Method
1) Haemodynamic Parameters-	Systolic Blood Pressure, Diastolic Blood Pressure, mean Arterial Pressure, End Tidal Carbon Dioxide, Oxygen Saturation as per Pulse Oximetry.

Trial Locations

Locations (1)

Government Medical College and Hospital, Sector-32, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital, Sector-32, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Deepanshu Rai

Principal investigator

9877803239

depanshurai@gmail.com