CompletedPhase 4ACTRN12614000790640

A Prospective Randomised Trial of Two Tidal Volume Ventilator Strategies in Patients Undergoing Major Surgery

A prospective randomised trial of intraoperative tidal volume ventilation with 6ml/kg (Ideal Body weight) and positive end expiratory pressure (PEEP) of 5 cm H2O versus 10ml/kg (Ideal Body weight) and PEEP of 5 cm H2O, in adult patients undergoing major surgery.


Sponsor

Departments of Intensive Care and Anaesthesia, Austin Hospital

Enrollment

1,240 participants

Start Date

Sep 1, 2014

Study Type

Interventional

Conditions

Summary

There is no good evidence to guide the choice of breath size (tidal volume) delivered by the breathing machine during anaesthesia. In a recent multi-centre study, we found that anaesthetists deliver a variable tidal volumes with some patients receiving low-tidal volumes (6-7 ml/kg) and others receiving high-tidal volumes (9-10 ml/Kg) according to clinician preference. We also found that they typically positive end expiratory pressure (PEEP) (pressure to keep lung when breathing out has been completed) at an average modest value of 5.0 cmH2O. Thus, in Victoria and the Austin hospital in patients under general anaesthesia administered tidal volume can be variably high or low and PEEP is often applied at modest levels. Because of such variability and the possibility that one approach or another may be better at avoiding lung complications after anaesthesia, we wish to perform prospective randomised trial to evaluate the impact and outcome of two different tidal volume strategies during anaesthesia. Specifically, we wish to conduct a pilot single-centre prospective randomised trial comparing a low tidal volume (6 ml/kg) to a higher tidal volume (10 ml/kg) tidal volume strategy in combination with PEEP at 5 cm H2O for patients undergoing major surgery. The anticipated sample size is 900 participants over a 18 month period. Patients will be randomly allocated to either low or control tidal volume ventilation for the period of their surgical procedure to test the hypothesis that one of these two approaches in superior at decreasing post-surgical lung complications.


Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Inclusion Criteria4

  • Patients will be eligible to participate in this study if:
  • The patient is aged 40 years or older
  • The treating anaesthetist expects that the patient will remain intubated for a period of equal to or greater than two hours
  • The patient will have an arterial line inserted for routine monitoring of blood pressure during the surgical procedure

Exclusion Criteria6

  • Patients will be ineligible for participation if:
  • The patient is pregnant and/or lactating
  • The patient has planned thoracic surgery
  • The patient has planned cardiac surgery
  • The patient has planned intracranial neurosurgery
  • Previously enrolment in this Trial

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Interventions

In patients undergoing major surgery who mechanical ventilation patients with an endotracheal tube, the ventilation strategy will be randomised to compare either a 6ml/kg or 10ml/kg tidal volume strat

In patients undergoing major surgery who mechanical ventilation patients with an endotracheal tube, the ventilation strategy will be randomised to compare either a 6ml/kg or 10ml/kg tidal volume strategy in combination with PEEP.


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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ACTRN12614000790640