Skip to content

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000790640
Acronym
Not applicable
Enrollment
1240
Registered
2014-07-24
Start date
2014-09-01
Completion date
2018-11-21
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 strategy in combination with PEEP.

Sponsors

Departments of Intensive Care and Anaesthesia, Austin Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients will be eligible to participate in this study if: 1. The patient is aged 40 years or older 2. The treating anaesthetist expects that the patient will remain intubated for a period of equal to or greater than two hours 3. The patient will have an arterial line inserted for routine monitoring of blood pressure during the surgical procedure

Exclusion criteria

Patients will be ineligible for participation if: 1. The patient is pregnant and/or lactating 2. The patient has planned thoracic surgery 3. The patient has planned cardiac surgery 4. The patient has planned intracranial neurosurgery 5. Previously enrolment in this Trial

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026