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CTRI Number  CTRI/2023/05/052446 [Registered on: 10/05/2023] Trial Registered Prospectively
Last Modified On: 09/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Better mode of ventilation - volume controlled or pressure controlled ventilation for patients with breast surgeries in terms if mechanical power 
Scientific Title of Study   Pressure versus Volume controlled ventilation to predict the incidence of postoperative pulmonary complications measuring Mechanical Power in breast surgeries - A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Greeshma Kongara 
Designation  Assistant Professor 
Affiliation  ESIC Medical College Hospital, Sanathnagar, Hyderabad 
Address  OT 3 rd floor, ESIC Medical College Hospital, Sanathnagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  8179952994  
Fax    
Email  Greeshmakongara@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Greeshma Kongara 
Designation  Assistant Professor 
Affiliation  ESIC Medical College Hospital, Sanathnagar, Hyderabad 
Address  OT 3 rd floor, ESIC Medical College Hospital, Sanathnagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  8179952994  
Fax    
Email  Greeshmakongara@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Greeshma Kongara 
Designation  Assistant Professor 
Affiliation  ESIC Medical College Hospital, Sanathnagar, Hyderabad 
Address  OT 3 rd floor, ESIC Medical College Hospital, Sanathnagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  8179952994  
Fax    
Email  Greeshmakongara@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College Hospital, Hyderabad, India 
 
Primary Sponsor  
Name  Department of anaesthesia 
Address  ESIC Medical College Hospital, Hyderabad, India 
Type of Sponsor  Government medical college 
 
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 Greeshma Kongara  ESIC Medical College Hospital  Anaesthesia department, 3rd floor, OT block, Hyderabad, Sanathnagar. PINCODE : 500018
Hyderabad
TELANGANA 
8179952994

greeshmakongara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, ESIC Medical College Hospital and Superspecialty Hospital, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pressure controlled ventilation  Preoperative lung ultrasound will be done on the day of surgery. Patients in this group will be ventilated with pressure controlled mode of ventilation with inspiratory pressure settings to generate tidal volume of 6 ml/kg of predicted body weight throughout intraoperative period. Respiratory rate and inspiratory pressure will be adjusted to maintain end tidal carbon dioxide between 34 - 38 mm of Hg. If the patient saturation and etCO2 are not maintained then the patient ventilatory settings will be changed accordingly and they will be excluded from the study. Mechanical power will be calculated using the formula. Postoperative lung ultrasound will be done and findings will be noted. Postoperative pulmonary complications will be noted, if any. 
Comparator Agent  Volume controlled Ventilation  Preoperative lung ultrasound will be done on the day of surgery. Patient will be ventilated with volume control mode of ventilation with tidal volume of 6 ml/kg of predicted body weight. Respiratory rate will be adjusted to maintain the end tidal carbon dioxide between 34 - 38 mm of Hg. If the patient saturation and etCO2 are not maintained then the patient ventilatory settings will be changed accordingly and they will be excluded from the study. Mechanical power will be calculated as per the formula. Postoperative lung ultrasound will be done. Postoperative pulmonary complications will be noted, if any. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Breast surgeries
Surgery duration > 2 hrs
 
 
ExclusionCriteria 
Details  Pregnant
Risk factors for pulmonary complications - BA,
Obesity, COPD
Previous respiratory complications
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of postoperative pulmonary complications, defined as positive if any component developed within the first three days after surgery. The diagnoses of atelectasis, pleural effusion and pneumothorax will be based on bedside ultrasound.
 
Bedside ultrasound is done in the immediate postoperative period. 
 
Secondary Outcome  
Outcome  TimePoints 
Acute respiratory failure within the first 3 days after surgery, unplanned ICU admission, total hospital stay.
 
Patient monitored for for 72 hours. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   15/05/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
INTRODUCTION: Postoperative pulmonary complications often occur in patients after major surgery incidence (2 – 6%) and result in attributable morbidity and mortality. The mechanical power of ventilation is a recently introduced ventilation parameter that summarizes the amount of energy per unit of time transferred from the ventilator to the respiratory system, and part of this energy acts directly on lung tissue where it can cause iatrogenic harm. The effects of the intraoperative mechanical power on the occurrence of postoperative pulmonary complications in PCV mode have not yet been investigated thoroughly. In theory, limiting the intraoperative mechanical power could reduce the risk for postoperative pulmonary complications and as such improve postoperative outcomes. Mechanical power in VCV MP (J/min) = 0.098×RR× TV×  (Ppeak - PEEP).  In that of PCV mode is MP(J/min) = 0.098×RR×TV(PEEP + ΔPinsp) [ΔPinsp = Pressure above PEEP (cm of H2O)].
METHODOLOGYPatients scheduled will have invasive arterial pressure monitoring as a part of their routine care. Patients will receive either Volume controlled Ventilation (VCV) or Pressure controlled Ventilation (PCV) mode of ventilation after a baseline ABG. Patients will be assigned to receive lung ventilation with either VCV mode with low tidal volume (VT) (6 ml/kg predicted body weight, PBW) or PCV mode to generate a volume equal to 6 ml per kg predicted body weight. The VT, FiO2 and PEEP will be fixed and maintained for the duration of the surgical procedure. All other aspects of intra-operative care, including the inspired fraction of oxygen (FiO2), respiratory rate, anaesthesia technique (including type of sedative used), fluid management, use of vasoactive drugs, analgesia plan, use of prophylactic antibiotics and antiemetics agents, will be administered at the discretion of the treating anaesthesiologist. Neuromuscular blocking agents will be used in all patients according to local protocol. On the day of surgery, baseline preoperative lung ultrasound will be done before surgery. Postoperative lung ultrasound is done after 24 hours and patient is monitored for 72 hours. Mechanical power is calculated to compare the efficacy between two modes of ventilation.
STATISTICS: All analyses were performed using R version 4.0.2 (R Foundation for Statistical Computing), and a two-sided P less than 0.05 was considered significant. Continuous variables will be reported as median with their interquartile ranges and categorical variables as total number & percentage (%). Proportions will be compared with Fisher exact tests and continuous variables will be compared using t test or Wilcoxon rank sum test, as appropriate. The following variables will be considered for adjustment : age, sex, baseline SpO2, baseline bicarbonate, randomisation group and the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score.
HYPOTHESIS: Pressure controlled ventilation is non – inferior to volume controlled ventilation in terms of mechanical power.
EXPECTED OUTCOME : Equal or lower incidence of post operative pulmonary complications in pressure controlled ventilation compared to volume controlled ventilation.
BENEFITS : Least postoperative pulmonary complications, so early mobilisation, lesser hospital days & early discharge.
NOVELTY OF STUDY: There are no studies based on mechanical power using pressure controlled ventilation in perioperative period.

 
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