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

NCT ID: NCT03637530

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-10-31

Brief Summary

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.

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.

Conditions

Lung Injury, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

intervention group

in this group of patients, inverse ratio ventilation is provided during general anaesthesia

Group Type: EXPERIMENTAL

inverse ratio ventilation

Intervention Type: OTHER

during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics

control group

in this group of patients, conventional ventilation is provided during general anaesthesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

inverse ratio ventilation

during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences, Rishikesh

OTHER_GOV

Sponsor Role: lead

Responsible Party

ADABALA VIJAY BABU

post graduate,department of Anesthesiology,AIIMS Rishikesh

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUKESH TRIPATHI, MD

Role: STUDY_DIRECTOR

PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH

References

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

Reference Type: BACKGROUND