| CTRI Number |
CTRI/2023/02/049658 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare the effects of two modes of ventilation (bi-level positive airway pressure ventilation and pressure regulated volume control ventilation mode) on surgical patients admitted in ICU requiring ventilatory support. |
|
Scientific Title of Study
|
Comparison of Bi-level positive Airway Pressure versus Pressure-Regulated Volume Control mode of ventilation in exploratory laparotomy patients in intensive care unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Kumari |
| Designation |
Post Graduate Junior Resident Trainee |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
Level 5
D Block
Government Medical College and Hospital
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
08340611074 |
| Fax |
|
| Email |
singhakkusingh7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj Kapoor |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
Room No 523
Level 5
D Block
Government Medical College and Hospital
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121549 |
| Fax |
|
| Email |
kapoor.dheeraj72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Kumari |
| Designation |
Post Graduate Junior Resident Trainee |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
Level 5
D Block
Government Medical College and Hospital
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
08340611074 |
| Fax |
|
| Email |
singhakkusingh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director Principal,Government medical College and Hospital, Sector 32, Chandigarh-160030 |
|
|
Primary Sponsor
|
| Name |
Director Principal Government Medical College and Hospital |
| Address |
Government medical College and Hospital, Sector 32,
Chandigarh-160030 |
| 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 Akanksha Kumari |
Government Medical College and Hospital, Sector 32, Chandigarh |
Department of
Anaesthesia and
Intensive Care, Level 5,
D Block, Government
Medical College and
Hospital, Sector 32,
Chandigarh
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
8340611074
Singhakkusingh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Core Committee, GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To study the effects of BIPAP ventilatory mode in surgical patients in ICU. |
Study the ventilatory and cardiopulmonary variables in patients undergoing Bi-level Positive Airway Pressure ventilatory mode of ventilation in post exploratory laparotomy patients in intensive care unit. |
| Comparator Agent |
To study the effects of PRVC ventilatory mode in surgical patients in ICU. |
Study the ventilatory and cardiopulmonary variables in patients undergoing Pressure Regulated Volume Control ventilatory mode of ventilation in post exploratory laparotomy patients in intensive care unit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients on invasive mechanical ventilation and admitted in ICU following exploratory laparotomy due to ARF for less than 24 hours,
2.Age group 18-60 years.
3.Stable hemodynamic parameters (Mean Arterial Pressure between 70 mm Hg - 100 mm Hg, Heart Rate between 60 - 100/minute, SPO2 - 90%)
4.Richmond Agitation–Sedation Scale (RASS)between 0 and -2 |
|
| ExclusionCriteria |
| Details |
1.Refusal of informed consent
2.Pregnant women
3.Morbidly obese patients (BMI>35)
4.Patients diagnosed with ARDS (Mild, Moderate or Severe)
according to Berlin’s definition.
5.Patients with severe or chronic heart, lung, hepatic or renal
disease
6.Patients with severe neuromuscular disorders
7.Patients on vasopressors, cardiac depressants or neuromuscular
blockers
8.Patients with traumatic brain injury
9.Patients with blunt or traumatic chest injury
10.Patients with severe multiple organ dysfunction. |
|
|
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 |
Ventilatory Parameters ( Peak airway pressure,
Platue pressure, Mean airway pressure, Mean
airway pressure, Compliance, Static compliance,
Airway resistance) |
T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation.
T2- 60 minutes after keeping on ventilator mode 1
T3- 120 minutes after keeping on ventilator mode 1
T4- 120 minutes after switching back on AC/VC
corresponding to time just before switching to study ventilator mode 2 as per allocation.
T5- 60 minutes after keeping on ventilator mode 2
T6- 120 minutes after keeping on ventilator mode 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Haemodynamic parameters-Systolic blood
pressure,Diastolic blood pressure,Mean arterial
blood pressure,Heart rate,End -tidal cardon
dioxide,Arterial oxygen saturation.
2)Arterial blood gas analysis parameters- pH,
Partial pressure of oxygen, Partial pressure of
carbon dioxide, Arterial oxygen saturation. |
T1- 120 minutes after keeping on AC/VC corresponding to time just before switching to study ventilator mode 1 as per allocation.
T2- 60 minutes after keeping on ventilator mode 1
T3- 120 minutes after keeping on ventilator mode 1
T4- 120 minutes after switching back on AC/VC
corresponding to time just before switching to study ventilator mode 2 as per allocation.
T5- 60 minutes after keeping on ventilator mode 2
T6- 120 minutes after keeping on ventilator mode 2 |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/02/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Mechanical ventilation in critical care is to deliver higher concentrations of oxygen into the lungs and elimination of carbon dioxide and hence curtailing the energy expenditure of patient efforts on breathing. There are several ventilation modes available on mechanical ventilators, each with advantages and disadvantages of their own. Bi-level positive airway pressure ventilation (BIPAP) is a biphasic mode of ventilation which allows spontaneous breathing to promote lung recruitment of poorly ventilated and collapsed alveoli. Biphasic positive airway pressure (BIPAP) mode of ventilation has unique characteristics, limiting the possible lung injury and assist in automatic weaning of patients from ventilator support. Previous studies done in patients having chronic obstructive lung disease (COPD), acute respiratory distress syndrome (ARDS) and in post-cardiac surgery requiring mechanical ventilation, have shown encouraging results, when kept on BIPAP ventilator mode. The results stimulated us to conduct the proposed randomized prospective study, comparing BIPAP and PRVC mode of ventilation, in post-exploratory laparotomy patients, requiring mechanical ventilation due to acute respiratory failure. |