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CTRI Number  CTRI/2019/04/018720 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 21/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparison between different modes of ventilation in lap cholecystectomy under general anaesthesia 
Scientific Title of Study   A prospective, randomized, comparative study between volume controlled, pressure controlled and pressure regulated volume controlled ventilation in improving respiratory dynamics during laparoscopic cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sukriti Chowdhury 
Designation  Post Graduate Trainee 
Affiliation  Midnapore Medical College 
Address  Dept. of Anaesthesiology, Midnapore Medical College, Midnapore, Paschim Medinipur.

Medinipur
WEST BENGAL
721101
India 
Phone    
Fax    
Email  chowdhury.sukriti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Debasish Bhar 
Designation  Associate Professor 
Affiliation  Midnapore Medical College 
Address  Dept. of Anaesthesiology, Midnapore Medical College, Midnapore, Paschim Medinipur

Kolkata
WEST BENGAL
721101
India 
Phone    
Fax    
Email  debasish77bhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Debasish Bhar 
Designation  Associate Professor 
Affiliation  Midnapore Medical College 
Address  Dept. of Anaesthesiology, Midnapore Medical College, Midnapore, Paschim Medinipur

Kolkata
WEST BENGAL
721101
India 
Phone    
Fax    
Email  debasish77bhar@gmail.com  
 
Source of Monetary or Material Support  
Office of the Principal, Midnapore Medical College, Govt. of West Bengal, Vidyasagar Road, Paschim Medinipur-721101. 
 
Primary Sponsor  
Name  Midnapore Medical College 
Address  Midnapore, Paschim Medinipur. Pin 721101 
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 Debasish Bhar  Surgery operation theatre  Operation Theatre A, Surgical OT Complex, Department of Surgery, Bidhan Block, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur- 721101 Medinipur WEST BENGAL
Medinipur
WEST BENGAL 
8697362730

debasish77bhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  35 patients (Group P) undergoing elective laparoscopic cholecystectomy under general anaesthesia will be ventilated with pressure controlled ventilation (PCV) and 35 patients (Group PV) will be ventilated with pressure regulated volume controlled ventilation (PRVC).  Ventilation will be carried out using Dameca Siesta i Whispa workstation in all patients. In PCV mode, ventilation will be started with airway pressure which is needed to deliver tidal volume of 8 mL/kg body weight. In PRVC mode a target tidal volume of 8 mL/kg will be set with airway pressure limit of 20 cm of H2O. Inspiratory to expiratory ratio (0.5), inspired oxygen concentration (40%) and positive end‑expiratory pressure of 5 cm of H2O will be same in both modes. During insufflation of the abdomen, the intra-abdominal pressure will be maintained between 12 to 15 mmHg in all patients. Initial respiratory rate will be 12 breaths/min, but after pneumoperitoneum is developed, the respiratory rate will be adjusted to achieve an end‑tidal carbondioxide (EtCO2) between 33 and 37 mm of Hg. 
Comparator Agent  35 patients (Group V) undergoing elective laparoscopic cholecystectomy under general anaesthesia will be ventilated with volume controlled ventilation (VCV).  Ventilation will be done using Dameca workstation. In VCV mode, patients will be ventilated with a tidal volume of 8 mL/kg body weight, respiratory rate of 12 breaths/min, inspiratory to expiratory ratio of 0.5, inspired oxygen concentration of 40% and positive end‑expiratory pressure of 5 cm of H2O. During insufflation of the abdomen, the intra-abdominal pressure will be maintained between 12 to 15 mmHg in all patients. After creating pneumoperitoneum, the respiratory rate will be adjusted to achieve an end‑tidal carbondioxide (EtCO2) between 33 and 37 mm of Hg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age- 18-60 years
2. ASA grade 1 & 2
3. Non-Smoker
4. Elective Laparoscopic cholecystectomy under General Anaesthesia
 
 
ExclusionCriteria 
Details  1. Preexisting lung diseases
2. Respiratory infections in the past 3 weeks
3. Having a body mass index >25
4. ASA Classes III & IV
5. Patients in whom ventilator settings could not be stabilized within 30 min of pneumoperitoneum in the allocated modes
•Laparoscopic surgery will be converted to open procedure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The arterial oxygen levels (PaO2) in three modes of ventilation by means of the arterial blood gas (ABG) analysis  ABG will be done 10 min after insufflation and just before desufflation 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the respiratory parameters (Tidal Volume, Respiratory Rate, Dynamic Compliance)
2. To compare other ventilation and oxygenation parameters (EtCO2, PaCO2, SpO2)
3. To compare the hemodynamic parameters (Heart rate and mean arterial pressure)
 
All the parameters will be recorded at 10 min after insufflation and just before desufflation in all patients.  
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   01/07/2019 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

BACKGROUND: Volume controlled ventilation (VCV) mode is the most commonly used conventional mode in anesthesia. VCV follows a constant flow pattern to deliver a preset tidal volume in the preset inspiratory time, thus ensuring constant minute ventilation. This flow pattern generates high inspiratory pressure that can lead to shear stress injury, barotrauma and volutrauma to the alveoli[1] leading to microatelectasis and inflammatory mediator release characteristic of ventilator‑associated lung injury.

Pressure controlled ventilation (PCV) mode came as an alternative mode in laparoscopic surgeries. PCV delivers tidal volume at a preset pressure and inspiratory time. The flow, unlike VCV, is decelerating. This flow pattern has a high initial rise followed by a decrease and helps to attain the tidal volume at lower peak inspiratory pressures, and oxygenation is also better due to the initial high flow rates. However, with changing lung compliance, the tidal volume delivered varies, and there is always a risk of hypoventilation or hyperventilation.

Pressure regulated volume controlled mode (PRVC) is a new mode introduced recently in anesthesia workstations. PRVC features a user select tidal volume target that is autoregulated and pressure controlled.[2] The ventilator calculates the compliance of the lung and establishes the lowest possible pressure to deliver the target tidal volume. It has the characteristic decelerating flow pattern, thus incorporating the benefits of both VCV and PCV.[3]

Recently, few studies comparing the efficacy of PRVC over other modes on selected surgical cohorts have been published with varying results. Boules NS et al. has not observed any difference in respiratory and ventilatory parameters. Oxygenation index was comparable between both PCV and PRVC modes of ventilation when compared in patients undergoing abdominal cancer surgery under general anaesthesia.[4]

Kothari A et al. had observed similar result when the compared patients’ undergoing laparoscopic cholecystectomy. In their study it was found that PCV and PRVC modes are superior to VCV mode in providing adequate oxygenation at lower peak inspiratory pressures but no significant difference has been observed between PCV and PRVC modes in context of oxygenation, airway pressure and compliance.[5]Kocis KC et al. in infants undergoing surgery for congenital heart disease has found PRVC mode superior to VCV.[6]

Due to varying results in different previous studies, in the present study we are going to compare conventional VCV mode with relatively newer PCV and PRVC modes of ventilation.

METHODOLOGY: 105 patients undergoing laparoscopic cholecystectomy under general anaesthesia will be randomly allocated to receive volume controlled (group V), pressure controlled (group P), or pressure regulated volume controlled (group PV) modes of ventilation. The randomization will be done after patients consented for the study. Randomization will be done by computer‑generated numbering system. A standard general anesthesia technique will be followed in all cases. Standard monitors including noninvasive blood pressure monitor, pulse oximeter, electrocardiogram, and capnogram will be done.

Ventilation will be carried out using Dameca Siesta i Whispa workstation in all patients. . In VCV mode, patients will be ventilated with a tidal volume of 8 mL/kg body weight In PCV mode, ventilation will be started with airway pressure which is needed to deliver tidal volume of 8 mL/kg body weight. In PRVC mode a target tidal volume of 8 mL/kg will be set with airway pressure limit of 20 cm of H2O. Inspiratory to expiratory ratio (0.5), inspired oxygen concentration (40%) and positive end‑expiratory pressure of 5 cm of H2O will be same in all modes. During insufflation of the abdomen, the intra-abdominal pressure will be maintained between 12 to 15 mmHg in all patients. Initial respiratory rate will be 12 breaths/ min in all patients, but after pneumoperitoneum is developed, the respiratory rate will be adjusted to achieve an end‑tidal carbondioxide (EtCO2) between 33 and 37 mm of Hg.

Arterial blood gas analysis (ABG) will be done in all patients 10 min after pneumoperitonium is developed and just before desufflation.

EXPECTED OUTCOME: In this study we will find out in which of these three ventilator modes volume controlled ventilation mode (VCV), pressure controlled ventilation mode (PCV) and pressure regulated volume controlled ventilation mode (PRVC), the airway pressures, gas exchange, oxygenation, and lung compliance are better maintained.

References:

1. Maeda Y, Fujino Y, Uchiyama A, Matsuura N, Mashimo T, Nishimura M. Effects of peak inspiratory flow on development of ventilator‑induced lung injury in rabbits. Anesthesiology 2004;101:722‑8.

2. Keszler M. Volume‑targeted ventilation. Early Hum Dev 2006;82:811‑8.

3. Keszler M, Abubakar K. Volume guarantee: Stability of tidal volume and incidence of hypocarbia. Pediatr Pulmonol 2004; 38:240‑5.

4. Boules NS, El Ramely MA. Does pressure-controlled ventilation–volume guaranteed differ from pressure-controlled ventilation in anesthetized patients. Ain-Shams Journal of Anesthesiology 2014; 07:96–100.

5. Kothari A, Baskaran D. Pressure‑controlled Volume Guaranteed Mode Improves Respiratory Dynamics during Laparoscopic Cholecystectomy: A Comparison with Conventional Modes. Anesthesia: Essays and Researches 2017;12(1): 206-11

6. Kocis KC, Dekeon MK, Rosen HK, Bandy KP, Crowley DC, Bove EL. Pressure-Regulated Volume Control vs Volume Control Ventilation in Infants After Surgery for Congenital Heart Disease. Pediatr Cardiol 2001; 22:233–7.
 
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