FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047449 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ventilation strategy in patients undergoing Open Abdominal Surgeries in Trendelenburg position. 
Scientific Title of Study   Intraoperative Lung-protective ventilation strategy for patients undergoing open Abdominal surgeries in Trendelenburg position: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neeradi Vishal Kumar 
Designation  postgraduate 
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Nizam’s Institute of Medical Sciences

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  vishalkumarneeradi7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shibany Padhy 
Designation  Associate Professor 
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Nizam’s Institute of Medical Sciences

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  drshibanipadhy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neeradi Vishal Kumar 
Designation  postgraduate 
Affiliation  Nizam’s Institute of Medical Sciences 
Address  Nizam’s Institute of Medical Sciences

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  vishalkumarneeradi7@gmail.com  
 
Source of Monetary or Material Support  
NIZAM’S INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  NIMS 
Address  NIMS,PANJAGUTTA, HYDERABAD  
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 
Vishal Kumar  Nizam’s Institute of Medical Sciences  department of anaesthesia and intensive care, speciality block, room number 302,Punjagutta, Hyderabad
Hyderabad
TELANGANA 
8500209005

vishalkumarneeradi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraoperative lung protective ventilation   Lung recruitment manoeuvres by applying step wise increase in PEEP 30min after intubaion,30min after abdominal retraction,60min before extubation and at extubation. Total duration of minimum 2hours 
Comparator Agent  Tidal volume of 8 to 10ml/kg, with no intraoperative PEEP and recruitment manoeuvres  Tidal volume of 8 to 10ml/kg, with no intraoperative PEEP and recruitment manoeuvres. Total duration of minimum 2hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with 18-65years of age
2.either gender
3. patients undergoing elective open abdominal surgeries in trendelenburg position
4.surgery duration of greater than 2hours
5.American Society of Anesthesiologists (ASA) physical status I,II,III .  
 
ExclusionCriteria 
Details  1.Refusal to participate in the study
2.Preexisting significant cardiac or pulmonary co morbidities (heart failure, intractable shock, Chronic obstructive pulmonary disease, Asthma, pulmonary infection, bronchiectasis, pulmonary metastases)
3.Preexisting abnormalities on chest X-ray or spirometry.
4.History of neuromuscular disease
5.Liver cirrhosis (Child B or C), or chronic renal failure with hemodialysis, and the
6.Need to continue prolonged mechanical ventilation after surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
intra- and postoperative changes in P/F.  intra- and postoperative changes in P/F, PaO2 before induction, 1hour after intubation and postoperative day 1 
 
Secondary Outcome  
Outcome  TimePoints 
differences between the two groups regarding PaO2, A-aO2; intraoperative Cdyn and Stat, and the incidence of atelectasis detected on chest x-ray on the first postoperative day.  differences between the two groups regarding PaO2, A-aO2; intraoperative Cdyn and Stat after intubation,30min after intubation,60min before extubation and at extubation, and the incidence of atelectasis detected on chest x-ray on the first postoperative day. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be sent for publication once the study is complete. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Extreme steep Trendelenburg position of 25-40 degrees could contribute to Atelectasis formation, particularly in dependent regions and elevate mechanical stress in pulmonary parenchyma, triggering significant perioperative pulmonary dysfunction. Administration of General Anesthesia further decreases the End -Expiratory lung volume (EELV) forming Atelectasis and leads to a deterioration in respiratory mechanics and gas exchange. Ventilation strategy employing high tidal volumes could over distend normal lungs, thereby activating a local inflammatory reaction. Furthermore , zero- positive end-expiratory pressure or low levels of positive end-expiratory pressure (PEEP) could induce repetitive collapse and reopening of Alveoli, which ultimately result in an inflammatory injury. In recent years , intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator- induced lung injuries  (VILI) by employing a low tidal volume (Vt), an appropriate level of PEEP and recruitment maneuvers (RMs). In recent years, intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator-induced lung injuries (VILI) by employing a low tidal volume (Vt), an appropriate level of PEEP , and recruitment maneuvers (RMs) .The goals of these interventions are to minimize alveolar over distention, to prevent repeated collapse and reopening of alveoli and to reduce atelectasis.

 
Close