Effect of low positive end expiratory pressure (PEEP) vs recruitment followed high PEEP on mechanical power and respiratory mechanics in patients with blunt thoracic trauma undergoing non thoracic surgery: A randomised control trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mechanical power differences between low PEEP and recruitment followed high PEEP groups during intra operative ventilation
研究概览
简要总结
Patients with blunt thoracic trauma undergoing non thoracic surgery will be screened for inclusion criteria during preoperative anesthesia check up. Once a patient fulfills the inclusion criteria, they will be informed about the aim and methodology of the study and informed consent will be obtained
Demographic, clinical, radiological and laboratory data will be collected from each participant (as available):
Age, sex, BMI, mechanism of injury, type of injury, time since injury, type of surgery, co morbidities, addiction habits, chest X-ray, hemogram, renal function tests, liver function tests, serum electrolytes, echo, ECG.
In the operating room, standard monitoring as per American Society of Anesthesiologists’ recommendation (3- lead ECG or 5 lead ECG as per requirement of the patient, pulse oximetry, NIBP) will be initiated, intravenous cannulation will be secured, Baseline vitals- Heart rate (HR), Systolic BP (SBP), Diastolic BP(DBP), Mean BP(MAP), SpO2 will be recorded. Baseline ABG will be taken and PaO2, PaCO2, FiO2 will be recorded.
Induction: Anesthesia will be induced with IV Fentanyl 2 microgram per kg, Propofol 2mg per kg and Atracurium 0.5mg per kg. Following which endotracheal intubation will be done.
Patients will undergo volume controlled mechanical ventilation, with an inspiratory to expiratory ratio (I:E) of 1:2, and a respiratory rate adjusted to normocapnia (35 to 45 mmHg). Tidal volume is set to 7ml per kg (PBW).
Maintenance: Anesthesia will be maintained with oxygen, air and isoflurane. Thereafter the patient will be randomized into the following 2 groups using computer generated table of random number.
- RM+ High PEEP Group: Recruitment will be done by sustained inflation technique, in which a continuous pressure of 30cm H2O will be applied to the airways for 30sec followed by application of high PEEP at 10cm H2O.
2. Low PEEP Group: PEEP set at 5cm H2O.
Intra operative lung mechanics i.e peak inspiratory pressure, mean airway pressure, plateau pressure, driving pressure and mechanical power will be calculated post induction, every 30minutes thereafter, and till the end of surgery before extubation in both the group.
Mechanical power of ventilator in Joules per min will be calculated.
ABG will be done post induction, every 30 minutes and at the end of surgery to assess PaO2, Alveolar arterial gradient, Respiratory index. Alveolar arterial gradient and Respiratory index will be calculated.
HR, SBP, DBP, MAP are recorded post induction, every 30 minutes, and at the end of surgery. Incidence of hypotension, need for vasopressor will be recorded. The MAP in both the groups will be targeted to more than 70mmHg. Intravenous ephedrine or norepinephrine will be used if required.
In both the groups, allowable blood loss (ABL) will be calculated.
Any volume of blood lost during the surgery below the calculated ABL will be replaced with crystalloids. The volume of blood lost more than the calculated ABL will be replaced with cross matched blood.
In both the groups, the patient will be sub-divided on the basis of chest trauma score for studying the impact of PEEP in BTT patients with varying degree of chest trauma.
Participants will be followed up to look for the development of Post operative pulmonary complications ( Barotrauma, Pulmonary edema, Pleural effusion, Bronchospasm, acute respiratory distress syndrome, Respiratory failure, new pulmonary infiltrates) for upto 48 hours post-surgery.
Protocol deviation: Anesthesiologists may deviate from the ventilation protocol at any time if concerns about patient safety arises. PEEP may be modified according to the anesthesiologist’s judgment in the presence of any of the following clinical situations: 1.Decrease in systolic arterial pressure less than 90mmHg and unresponsive to fluids and/or vasoactive drugs. 2. Need for a dosage of vasoactive drugs at the tolerance limit. 3. New arrhythmias unresponsive to the treatment suggested by the Advanced Cardiac Life Support Guidelines. 4. Blood loss requiring massive transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with blunt thoracic trauma undergoing non thoracic surgery under general anaesthesia with mechanical ventilation.
排除标准
- •a) Patient refusal to participate in the study b) Known COPD or other chronic lung diseases.
- •c) Patients with penetrating thoracic trauma.
- •d) Pre existing cardiac dysfunction.
- •e) Patients undergoing thoracic or cardiac surgery.
- •f) Presence of uncontrolled arrhythmias or significant hemodynamic instability.
- •h) Pregnancy I) Patients already intubated and ventilated for more than 24 hours prior to surgery.
结局指标
主要结局
Mechanical power differences between low PEEP and recruitment followed high PEEP groups during intra operative ventilation
时间窗: After Induction, every 30 minutes and at the end of surgery.
次要结局
- To assess differences in respiratory mechanics(After induction, every 30 minutes and at the end of surgery.)
- To evaluate oxygenation(After induction, every 30 minutes and at the end of surgery.)
- To compare hemodynamic effects(After induction, every 30 minutes and at the end of surgery.)
- To assess post operative pulmonary complications(Upto 48 hours after surgery)
研究者
Dr. Rushika Kowdipally
AIIMS New Delhi