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CTRI Number  CTRI/2024/11/076650 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 17/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Suctioning in patients on Mechanical Ventilation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial comparing the efficacy of PEEP ZEEP technique to conventional method of suctioning in reducing incidence of ventilator associated pneumonia in patients on invasive mechanical ventilation.  
Scientific Title of Study   Efficacy in Reduction of Ventilator Associated Pneumonia in Patients with Invasive Mechanical Ventilation with PEEP ZEEP Technique Vs Conventional Method of Suctioning:A Randomised Controlled Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rishabh Gaur 
Designation  PGJR Dept of Anesthesiology 
Affiliation  Heritage Institute of Medical Sciences,Varanasi 
Address  Critical Care Unit,Heritage Institute of Medical Sciences, NH-2 Bypass, Bhadwar, Varanasi

Varanasi
UTTAR PRADESH
221311
India 
Phone  9621053590  
Fax    
Email  rishi2512gaur@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sulakshana 
Designation  Associate Professor Department of Anesthesiology 
Affiliation  Heritage Institute of Medical Sciences,Varanasi 
Address  Critical Care Unit,Heritage Institute of Medical Sciences, NH-2 Bypass, Bhadwar, Varanasi

Varanasi
UTTAR PRADESH
221311
India 
Phone  9389848829  
Fax    
Email  dr.sulakshanatripathi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sulakshana 
Designation  Associate Professor Department of Anesthesiology 
Affiliation  Heritage Institute of Medical Sciences,Varanasi 
Address  Critical Care Unit,Heritage Institute of Medical Sciences,NH-2 Bypass,Bhadwar,Varanasi

Varanasi
UTTAR PRADESH
221311
India 
Phone  9389848829  
Fax    
Email  dr.sulakshanatripathi@gmail.com  
 
Source of Monetary or Material Support  
Heritage Institute of Medical Sciences,NH-2,Bhadwar,Varanasi-221311,India 
 
Primary Sponsor  
Name  Heritage Institute of Medical Sciences 
Address  NH-2,Bhadwar,Varanasi-221311,U.P.,India 
Type of Sponsor  Private 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 Rishabh Gaur  Heritage Institute of Medical Sciences  Critical Care Unit,Heritage Institute of Medical Sciences,NH-2,Bhadwar,Varanasi-221311
Varanasi
UTTAR PRADESH 		 9621053590

rishi2512gaur@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Heritage Institute of Medical Sciences,Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J159||Unspecified bacterial pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Method of Suctioning in patients on mechanical ventilation via Conventional Method  Patient will be preoxygenated with 100% Fio2 for 1 minute,followed by introduction of atoxic,sterile,PVC 14 FG suction catheter.The catheter will be introduced until resistance is met, and it will then be withdrawn 2–3 cm with a negative pressure of ∼150 mm Hg, applied for 15 s with circular movements  
Intervention  Method of Suctioning in patients on mechanical ventilation via PEEP ZEEP   Patient will be Ventilated with PEEP 15cm H2O,PIP 40 CM H2O for 1 min and Fio2-20% above baseline via Mindray SV300 ventilator. After 1minute,PEEP will be abruptly reduced to zero and bilateral thoracic compression will be given,ventilator will be disconnected and another person will be suctioning out via atoxic,sterile,PVC 14FG suction catheter and post procedure the ventilator will be reconnected without change in initial parameters.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All age more than 18 years on controlled mechanical ventilation for more than 72 hours 
 
ExclusionCriteria 
Details  Patient/Attendant refusal.
Rib fracture
ICD insitu
Emphysematous bulla
Pneumothorax
Pleural Effusion
Hemodynamic instability requiring noradrenaline more than 10 mcg/min
PEEP requirement more than 12 cm H2O for SpO2 more than 92%.
Severe bronchospasm(PIP-PPlat more than 20 cm H2O) .
Severe Hypoalbuminemia (S.Albumin less than 2.5 g/dl)
Ejection fraction less than 40%.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The PEEP-ZEEP technique has been proven to be a safe suction technique,which improves oxygenation without altering hemodynamics in intubated and mechanically ventilated patients. Compared to conventional suction technique it produces elevated expiratory flow that increases the movement of secretions towards the glottis.Hence, this elevated expiratory flow should decrease the incidence of Ventilator Associated Pneumonia in comparison to conventional method of suctioning.
 		 Baseline Samples will be collected before suctioning then,Immediately after then 20 mins post suctioning 
 
Secondary Outcome  
Outcome  TimePoints 
1)To study the effect of suctioning method on PaO2 and PaCo2 in patients on invasive mechanical ventilation.
2) To study the hemodynamic alterations due to suctioning by PEEP ZEEP technique Vs Conventional method in patients on invasive mechanical ventilation 		 Immediately before initiation of suctioning, immediately after and 20 minutes post suctioning. 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   22/11/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
•Ventilator-associated pneumonia (VAP) refers to pneumonia developed in patients who have been mechanically ventilated for a duration of more than 48 h  and is a major cause of hospital morbidity and mortality. Its incidence differs between 5% and 50% in mechanically ventilated patients 
•Critically ill patients with artificial airways have shown changes in mucociliary clearance with the accumulation of secretions due to sedation, depression of the cough reflex, inadequate cuff pressure, inflammation, and mucosal trauma.
•Airway suctioning is often necessary to maintain alveolar permeability and to prevent respiratory tract infection,its classical procedure consists of disconnection from mechanical ventilation, followed by insertion of a suction catheter into the trachea for tracheal suctioning under negative pressure
•According to the guidelines of the American Association for Respiratory Care (AARC),this procedure may result in numerous side effects,such as risks and complication for developing  hypoxia due to reduced tissue oxygenation(Pa02),peripheral oxygen saturation (SPo2),trauma to bronchial mucosa with hemorrhagic secretion ,elevated carbon dioxide levels in the blood(Paco2)  ,changes in hemodynamics
•Difference between Peak expiratory flow rate and Peak inspiratory flow rate >33L/min facilitates the movements of expectoration/secretions  .
•Bacterial transfer from naso-oropharynx and gut to the lower respiratory tract in mechanically ventilated patients via endotracheal tube cuff or by direct cross contamination during nursing intervention results in VAP development.
•Studies have reported that Fio2 1.0 should be the method of choice to prevent lower levels of Pao2 and Spo2, especially during open endotracheal suctioning, as recommended by the latest guidelines of the AARC.
•The PEEP-ZEEP technique is described as a lung inflation through a positive pressure enhancement at the end of expiration (PEEP), followed by rapid lung deflation with an abrupt reduction in the PEEP to 0 cmH2O (ZEEP), associated to a manual bilateral thoracic compression.
•The PEEP-ZEEP technique seems to be safe, without alterations on hemodynamic variables, produces elevated expiratory flow and seems to be an alternative technique for the removal of bronchial secretions in patients .
Aim is to compare the incidence of Ventilator Associated Pneumonia(VAP) between PEEP ZEEP technique Vs conventional method of suctioning in patients with endotracheal/tracheostomy tubes.

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