| 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
|
|
|
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
|
|
|
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. |