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CTRI Number  CTRI/2024/03/064934 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How different ventilator breathings settings affect breathing problems after emergency surgery : A Research Study 
Scientific Title of Study   Comparison of the effect of volume controlled ventilation versus pressure controlled ventilation-volume guaranteed on postoperative pulmonary complications in emergency laparotomy : A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitin Jassal 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Room no. 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS New Delhi, South DELHI 110029, India

South
DELHI
110029
India 
Phone  9462582815  
Fax    
Email  nitin.jassal555@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sulagna Bhattacharjee 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS New Delhi, South DELHI 110029, India

South
DELHI
110029
India 
Phone  9818212531  
Fax    
Email  bhattacharjee.sulagna85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nitin Jassal 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Room no. 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS New Delhi, South DELHI 110029, India

South
DELHI
110029
India 
Phone  9462582815  
Fax    
Email  nitin.jassal555@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari Nagar, 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari Nagar, New Delhi, 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitin Jassal  AIIMS New Delhi  Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, Ansari Nagar, 110029
South
DELHI 
9462582815

nitin.jassal555@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for postgraduate research, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V00-Y99||External causes of morbidity, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (5) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (6) ICD-10 Condition: C00-D49||Neoplasms, (7) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pressure controlled ventilation-volume guaranteed  After induction of anaesthesia, patient will be ventilated with pressure controlled ventilation-volume guaranteed with tidal volume of 6 to 8 millilitres per kilogram of predicted body weight. 
Comparator Agent  Volume controlled ventilation  After induction of anesthesia, patient will be ventilated with volume controlled ventilation with tidal volume of 6 to 8 millilitres per kilogram of predicted body weight throughout the surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients of either sex, undergoing emergency laparotomy under general anaesthesia, with expected duration of more than 2 hours, after giving informed written consent for participation in the study. 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Pregnancy
3. BMI of more than 35 kilograms per meter square or less than 18 kilograms per meter square
4. Known pre-existing severe or progressive chronic lung diseases
5. Preoperative diagnosis of pneumonia
6. Deformities of chest wall or thoracic spine
7. Pre-existing significant cardiac, renal or hepatic diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess whether pressure controlled ventilation-volume guaranteed (PCV-VG) has a lesser incidence of postoperative pulmonary complications (POPC) up to 7 days of surgery over a volume controlled ventilation (VCV).  Incidence of postoperative pulmonary complications (POPC) at post operative day 0, 1, 2, 3, 4, 5, 6 and 7. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess intraoperative lung mechanics i.e. compliance, airway pressures, driving pressures and mechanical power.  10 min after induction, hourly thereafter, and at the end of surgery before extubation. 
To assess the association of mechanical power and postoperative pulmonary complications (POPC).  Upto 7 days after surgery. 
To assess the preoperative and postoperative lung ultrasound aeration score.  Before induction and 30 minutes after extubation. 
To characterize the postoperative pulmonary complications according to the European Perioperative Clinical Outcomes definitions.  Upto 7 days after surgery. 
To assess oxygen free days at day-28 post randomization or till hospital discharge.  At day-28 post randomization or till hospital discharge. 
To assess duration of hospital stay.  At hospital discharge. 
To assess hospital mortality.  At hospital mortality. 
To assess intraoperative & postoperative oxygenation status.  Intraoperatively and 30 minutes after extubation. 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The term postoperative pulmonary complication (PPC) encompasses almost any complication affecting the respiratory system after anaesthesia and surgery. Emergency laparotomy surgery is a high-risk surgical procedure performed to address acute abdominal conditions, such as perforated bowel, abdominal trauma, and abdominal sepsis. While this intervention is often life-saving, it carries a significant risk of postoperative pulmonary complications (PPCs) that can lead to prolonged hospital stays, increased healthcare costs, and elevated mortality rates. Immediate changes in the respiratory system become apparent upon the induction of general anesthesia. These alterations include shifts in respiratory drive and muscle function, a reduction in lung volumes, and the occurrence of atelectasis in more than 75% of patients who are administered neuromuscular blocking drugs. 

PPCs are important causes of mortality after major noncardiac surgeries, and they adversely affect several aspects of morbidity, including hospital stay and unexpected ICU admissions. Their incidence is reported in a wide range (2.8-40%) depending mostly on the represented patient population and PPC definitions. Even though no single universal definition exists, there is a widespread consensus about the involvement of the following in its description: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis while others add pulmonary oedema and tracheal reintubation as well. In 2015, a European joint task force published guidelines for perioperative clinical outcome (EPCO) definitions.

High PEEP with recruitment maneuvers during low tidal volume ventilation in patients undergoing major surgery did not reduce postoperative pulmonary complications. Volume controlled ventilation (VCV) delivers a constant preset tidal volume, and airway pressure depends on pulmonary compliance. Pressure controlled ventilation (PCV) provides a constant preset tidal volume with decelerating flow, reducing peak airway pressures (Ppeak). Pressure controlled ventilation-volume guaranteed (PCV-VG), similar to PCV, uses decelerating flow and adjusts inspiratory pressure to achieve the set tidal volume based on measured dynamic compliance (Cdyn) at each breath. Pressure Controlled Ventilation-Volume Guaranteed (PCV-VG) mode of ventilation is found to have improved respiratory mechanics and oxygenation at lower peak inspiratory pressures in laparoscopic surgeries. The combination of PCV-VG and individualized PEEP, determined by static pulmonary compliance-directed titration, reduced inflammatory responses and lung injury markers and helped prevent atelectasis and hypoventilation in patients undergoing laparoscopic surgery in the Trendelenburg position. PCV-VG provided advantages such as lower peak airway pressure, plateau pressure, and higher dynamic airway compliance during two-lung ventilation as compared to volume controlled ventilation (VCV) in patients undergoing major elective non-cardiac surgery under general anesthesia. PCV-VG led to improved patient oxygenation, significantly lower peak airway pressure (Ppeak) and plateau pressure, and slightly lower mean airway pressure (Pmean) during one-lung ventilation (OLV) in thoracic surgery.

Lower peak airway pressures may lead to less barotrauma and volutrauma and reduced inflammatory responses which lead to postoperative pulmonary complications (PPC). 

No significant studies focusing on the PCV-VG ventilation mode in emergency surgeries are there. With its various advantages over VCV ventilation mode, it would be beneficial to study the PCV-VG ventilation mode in emergency settings.

We hypothesized that the incidence of postoperative pulmonary complications (POPC) will be less with Pressure Controlled Ventilation-Volume Guaranteed (PCV-VG) over Volume Controlled Ventilation (VCV) in adult patients undergoing emergency laparotomy surgery.

The primary objective of the study is to assess whether PCV-VG ventilation has a lesser incidence of POPC up to 7 days of surgery over a VCV ventilation.

 
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