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
|
|
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
|
|
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)]. METHODOLOGY: Patients 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. |