| CTRI Number |
CTRI/2024/03/064934 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How different ventilator breathings settings affect breathing problems after emergency surgery : A Research Study |
|
Scientific Title of Study
|
Comparison of the effect of volume controlled ventilation versus pressure controlled ventilation-volume guaranteed on postoperative pulmonary complications in emergency laparotomy : A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitin Jassal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS New Delhi, South DELHI 110029, India
South DELHI 110029 India |
| Phone |
9462582815 |
| Fax |
|
| Email |
nitin.jassal555@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sulagna Bhattacharjee |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS New Delhi, South DELHI 110029, India
South DELHI 110029 India |
| Phone |
9818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nitin Jassal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS New Delhi, South DELHI 110029, India
South DELHI 110029 India |
| Phone |
9462582815 |
| Fax |
|
| Email |
nitin.jassal555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari Nagar, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari Nagar, New Delhi, 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitin Jassal |
AIIMS New Delhi |
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, Ansari Nagar, 110029 South DELHI |
9462582815
nitin.jassal555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for postgraduate research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (5) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (6) ICD-10 Condition: C00-D49||Neoplasms, (7) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pressure controlled ventilation-volume guaranteed |
After induction of anaesthesia, patient will be ventilated with pressure controlled ventilation-volume guaranteed with tidal volume of 6 to 8 millilitres per kilogram of predicted body weight. |
| Comparator Agent |
Volume controlled ventilation |
After induction of anesthesia, patient will be ventilated with volume controlled ventilation with tidal volume of 6 to 8 millilitres per kilogram of predicted body weight throughout the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex, undergoing emergency laparotomy under general anaesthesia, with expected duration of more than 2 hours, after giving informed written consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Pregnancy
3. BMI of more than 35 kilograms per meter square or less than 18 kilograms per meter square
4. Known pre-existing severe or progressive chronic lung diseases
5. Preoperative diagnosis of pneumonia
6. Deformities of chest wall or thoracic spine
7. Pre-existing significant cardiac, renal or hepatic diseases |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether pressure controlled ventilation-volume guaranteed (PCV-VG) has a lesser incidence of postoperative pulmonary complications (POPC) up to 7 days of surgery over a volume controlled ventilation (VCV). |
Incidence of postoperative pulmonary complications (POPC) at post operative day 0, 1, 2, 3, 4, 5, 6 and 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess intraoperative lung mechanics i.e. compliance, airway pressures, driving pressures and mechanical power. |
10 min after induction, hourly thereafter, and at the end of surgery before extubation. |
| To assess the association of mechanical power and postoperative pulmonary complications (POPC). |
Upto 7 days after surgery. |
| To assess the preoperative and postoperative lung ultrasound aeration score. |
Before induction and 30 minutes after extubation. |
| To characterize the postoperative pulmonary complications according to the European Perioperative Clinical Outcomes definitions. |
Upto 7 days after surgery. |
| To assess oxygen free days at day-28 post randomization or till hospital discharge. |
At day-28 post randomization or till hospital discharge. |
| To assess duration of hospital stay. |
At hospital discharge. |
| To assess hospital mortality. |
At hospital mortality. |
| To assess intraoperative & postoperative oxygenation status. |
Intraoperatively and 30 minutes after extubation. |
|
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Target Sample Size
|
Total Sample Size="106" Sample Size from India="106"
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)
|
02/04/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The term postoperative pulmonary complication (PPC) encompasses almost any complication affecting the respiratory system after anaesthesia and surgery. Emergency laparotomy surgery is a high-risk surgical procedure performed to address acute abdominal conditions, such as perforated bowel, abdominal trauma, and abdominal sepsis. While this intervention is often life-saving, it carries a significant risk of postoperative pulmonary complications (PPCs) that can lead to prolonged hospital stays, increased healthcare costs, and elevated mortality rates. Immediate changes in the respiratory system become apparent upon the induction of general anesthesia. These alterations include shifts in respiratory drive and muscle function, a reduction in lung volumes, and the occurrence of atelectasis in more than 75% of patients who are administered neuromuscular blocking drugs. PPCs are important causes of mortality after major noncardiac surgeries, and they adversely affect several aspects of morbidity, including hospital stay and unexpected ICU admissions. Their incidence is reported in a wide range (2.8-40%) depending mostly on the represented patient population and PPC definitions. Even though no single universal definition exists, there is a widespread consensus about the involvement of the following in its description: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis while others add pulmonary oedema and tracheal reintubation as well. In 2015, a European joint task force published guidelines for perioperative clinical outcome (EPCO) definitions. High PEEP with recruitment maneuvers during low tidal volume ventilation in patients undergoing major surgery did not reduce postoperative pulmonary complications. Volume controlled ventilation (VCV) delivers a constant preset tidal volume, and airway pressure depends on pulmonary compliance. Pressure controlled ventilation (PCV) provides a constant preset tidal volume with decelerating flow, reducing peak airway pressures (Ppeak). Pressure controlled ventilation-volume guaranteed (PCV-VG), similar to PCV, uses decelerating flow and adjusts inspiratory pressure to achieve the set tidal volume based on measured dynamic compliance (Cdyn) at each breath. Pressure Controlled Ventilation-Volume Guaranteed (PCV-VG) mode of ventilation is found to have improved respiratory mechanics and oxygenation at lower peak inspiratory pressures in laparoscopic surgeries. The combination of PCV-VG and individualized PEEP, determined by static pulmonary compliance-directed titration, reduced inflammatory responses and lung injury markers and helped prevent atelectasis and hypoventilation in patients undergoing laparoscopic surgery in the Trendelenburg position. PCV-VG provided advantages such as lower peak airway pressure, plateau pressure, and higher dynamic airway compliance during two-lung ventilation as compared to volume controlled ventilation (VCV) in patients undergoing major elective non-cardiac surgery under general anesthesia. PCV-VG led to improved patient oxygenation, significantly lower peak airway pressure (Ppeak) and plateau pressure, and slightly lower mean airway pressure (Pmean) during one-lung ventilation (OLV) in thoracic surgery. Lower peak airway pressures may lead to less barotrauma and volutrauma and reduced inflammatory responses which lead to postoperative pulmonary complications (PPC). No significant studies focusing on the PCV-VG ventilation mode in emergency surgeries are there. With its various advantages over VCV ventilation mode, it would be beneficial to study the PCV-VG ventilation mode in emergency settings. We hypothesized that the incidence of postoperative pulmonary complications (POPC) will be less with Pressure Controlled Ventilation-Volume Guaranteed (PCV-VG) over Volume Controlled Ventilation (VCV) in adult patients undergoing emergency laparotomy surgery. The primary objective of the study is to assess whether PCV-VG ventilation has a lesser incidence of POPC up to 7 days of surgery over a VCV ventilation. |