Comparison two types of artificial respiration in severe COVID-19 patients
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/08/027502
- Lead Sponsor
- Dr Souvik Maitra
- Brief Summary
Mechanical Ventilation Protocol
All patients were initially ventilated with volume assisted-control ventilation (VCV) using a *Drager Savina 300* ventilator prior to randomization to the APRV study arm or LTV study arm. In both groups, the mechanical ventilation goals were to maintain plateau airway pressure (Pplat) at no more than 30 cmH2O, PaO2 at between 55- and 100-mm Hg (or pulse oximeter between 88 and 98%), and arterial pH at ≥7.30 and tidal volume will be 6ml/ kg of predicted body weight (PBW) as previously described [1]. Patients will be randomized to any one of the treatment arms (LTV or APRV) as per protocol.
Low Tidal Volume Ventilation
In the LTV group, tidal volume target will be 6 mL/ kg PBW, with allowances for 4–8 mL/kg PBW to minimize asynchrony between the patient and ventilator; PEEP levels will be adjusted by the ARDSnet PEEP-FiO2 table, and then tidal volume and the respiratory rate will be regulated to achieve the above target pH. When PFR is < 150, PEEP will be tittered on the basis of lowest driving pressure.
ARPV
Patients will be transitioned from their previous volume assist-controlled ventilation to APRV with the following initial settings: high airway pressure (Phigh) of at the Pplat measured during previous VCV settings, not to exceed 30 cm H2O; low airway pressure (Plow) will be set at 5 cm H2O (minimal pressure level was used to prevent atelectasis per standard practice); duration of release (Tlow) will be set as 1.5 times of expiratory time constant and further adjusted to achieve 75% of peak expiratory flow rate. Thigh will be around 5s to achieve a release frequency of 10- 14/min.
Sedation & Analgesia
Analgesia target level was a Critical-Care Pain Observational Tool (CPOT) score of 0–2, and the sedation goal was a Richmond Agitation Sedation Scale (RASS) score of − 2 to 0.
Rescue Therapy
Attending physicians were allowed to use rescue therapy (neuromuscular blocking agents, recruitment maneuver, prone positioning etc.) and the indication for the same will be documented. Physicians will also be allowed to cross-over ventilation protocol if required.
Weaning form Mechanical Ventilation
Readiness for weaning will be assessed daily. Those patients are eligible for weaning, will undergo a 30-min SBT with a pressure support ventilation of 5–7 cmH2O, PEEP of 5 cmH2O, and FiO2 of ≤40%. In the APRV group, in the first stage, Phigh will be gradually reduced by 2 cmH2O, simultaneously with a reduction in release rate by two frequencies/min, twice daily unless the patient’s cardiopulmonary function deteriorated. In the second stage, when patients achieved the criteria with a Phigh of 20 cmH2O on 40% FiO2, same weaning protocol will be applied. When SBT is successful, attending physician will take the decision to extubate or not.
General Management
Standard intensive care protocol as per current guidelines for general nursing care, nutrition etc. will be followed. Fluid and vasopressor management will be guided by hemodynamic variables and point of care ultrasound. Broad spectrum antibiotics will be initiated at presentation as per institute protocol and appropriate cultures (blood, urine, abdominal fluid and tracheal aspirate whenever suitable) will be sent and antibiotic therapy will be tailored accordingly. Administration of steroid and tocilizumab will be as per clinical scenario and decided by the attending physician.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 216
Adult patients (aged between 18 & 75y) of either sex with laboratory confirmed SARS- CoV-2 infection, fulfilling Berlin definition of ARDS requiring invasive mechanical ventilation will be included in this study.
1.Refusal to participate 2.Moribund patients with life expectancy less than 48h 3.Pregnancy 4.Patients requiring more than 20mcg/min of noradrenalin support or equivalent dose of another inotropes/ vasopressor 5.Co-existing chronic obstructive pulmonary disease 6.Co- existing Neuro-muscular diseases 7.Recruitment in another randomized trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method whether APRV reduces intensive care unit (ICU) mortality over LTV in mechanically ventilated SARS- CoV-2 infected patients with ARDS 28- day post randomization
- Secondary Outcome Measures
Name Time Method 1.To compare the ventilator free days (VFD) in both the groups At day 28- post randomization 2.To compare hospital mortality in both the groups Till hospital discharge 3.To compare length of hospital stay in both the groups. Till hospital discharge 4.To compare oxygenation status 5.To compare hemodynamic status 9.To compare the incidence of barotrauma 10.To compare the proportion of patients extubated 7.To compare vasopressor free days (VFD) 8.To compare sedation free days (SFD)
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
All India Institute of Medical Sciences🇮🇳South, DELHI, IndiaDr Souvik MaitraPrincipal investigator8146727891souvikmaitra@live.com