a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries

A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery

Carbon dioxide insufflations of abdomen are integral part of laparoscopic operations in minimally invasive surgery era. It does cause splinting effect on diaphragm movement and set it high inside thoracic cavity too. In turn it will be associated with increase in peak and plateau airway pressure during positive pressure ventilation. Inverse ratio ventilation has been shown to improve lung compliance and restrict the peak and plateau airway pressure and should be useful as one of the lung protective ventilation method to improve respiratory outcome in laparoscopy surgery.

Study Overview

• Status: Unknown
• Conditions: Lung Injury, Acute
• Intervention / Treatment: Other: inverse ratio ventilation

Detailed Description

Anaesthesiologists have been ventilating patients in the perioperative period with relatively large tidal volumes (10-15 ml/kg ideal body weight) to prevent intraoperative atelectasis. Ventilating patient with large tidal volumes may be a risk factor for development of lung injury.During surgical procedures, both general anesthesia and high tidal volumes may strain non injured lungs and trigger inflammation. High tidal volumes that cause alveolar overstretching can contribute to extra pulmonary organ dysfunction through systemic release of inflammatory mediators.

Recently protective lung ventilation strategies has been reported to be useful to reduce the respiratory complications in postoperative period. The use of small tidal volume (Vt), positive end-expiratory pressure (PEEP) and restricting peak airway pressure have shown reduced incidence of ventilation induced lung injury.

It has been shown that a small tidal volume (VT) and PEEP can reduce the incidence of postoperative lung dysfunction and improve intraoperative oxygenation. Restricting peak airway pressure can be achieved by inverse ratio ventilation. Minimizing the risk of ventilator-induced lung injury (VILI), improving oxygenation and alveolar recruitment are all advantages of inverse ratio ventilation. However, the potential utility of pressure controlled inverse ratio ventilation (PCIRV) has not been studied in patients undergoing general anaesthesia.

Investigators hypothesized that in patients with normal lungs scheduled for general anesthesia, PIV might prevent lung function deterioration and lung morphological alterations. Investiagators aim was to compare the intraoperative protective ventilation strategies on oxygenation/ ventilation and postoperative lung dysfunction and lung injury among patients undergoing laparoscopic upper abdominal surgery.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-60 years
• ASA- I and II
• Patients undergoing laparoscopic upper abdominal surgery

Exclusion Criteria:

• Significant pulmonary disease
• Significant cardiac dysfunction
• BMI>30 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; in this group of patients, inverse ratio ventilation is provided during general anaesthesia	Other: inverse ratio ventilation; during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics
No Intervention: control group; in this group of patients, conventional ventilation is provided during general anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in partial pressure of oxygen from baseline	Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures	upto 1 day postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in pulmonary function tests from baseline	Investigators assume that the pulmonary function tests will be improved as we ventilate with inverse ratio ventilation as a protective lung strategy	upto 3 days postoperatively

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, Rishikesh
• Investigators: Study Director: MUKESH TRIPATHI, MD, PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH

Publications and helpful links

General Publications

• 8. Wang, X.Q., Wang, P.M., Wang, K.G., Jiang, T. and Xu, Z. Pressure-Controlled Inverse Ratio Ventilation during General Anesthesia for Open Abdominal Surgery Improves Postoperative Pulmonary Function. J. Biomedical Science and Engineering, 9, 17-24

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Acute Lung Injury; Lung Injury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I would like to share the results of my trail once it gets completed so that the effectiveness of the intervention will be known to others

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No