The role of protective intra-operative ventilation with alveolar recruitment strategies in minimising acute lung injury in lung transplantation.

A randomised controlled trial in adult lung transplantation patients comparing low tidal volume and PEEP versus pressure controlled ventilation, recruitment manoeuvres and PEEP, in order to establish whether one technique is more beneficial at preventing acute lung injury.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000403831

Enrollment

Registered

2012-04-10

Start date

2012-07-01

Completion date

2013-07-31

Last updated

2020-05-25

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

Conditions

None listed

Brief summary

Single-centre, randomised-controlled trial with a comparison of two protective ventilation techniques in order to determine the effect on the incidence of acute lung injury/ischaemia-reperfusion injury. Primary aims: 1. To determine the incidence and severity of acute lung injury post lung transplantation. 2. To determine the incidence of inflammatory markers in serum and bronchoalveolar lavage samples during anf after lung transplantation 3. To analyse the association between inflammatory markers and acute lung injury 4. To determine whether there is a decrease in the level of inflammation and incidence of acute lung injury associated with pressure-controlled, high positive end-expiratory pressure and alveolar recruitment Secondary aims: 1. To determine whether further protective ventilation techniques should be incorporated into lung transplantation anaesthesia. Hypothesis: Pressure-controlled ventilation and high positive end-expiratory pressure with the addition of alveolar recruitment will be more beneficial in minimising acute lung injury than low tidal volume protective ventilation alone in lung transplantation after allograft insertion.

Interventions

Pressure-controlled ventilation 16cmH2O, repeated recruitment manoeuvres, positive end-expiratory pressure 10cmH2O with a tidal volume limit of 10ml/kg for two-lung ventilation and 6ml/kg for one-lung ventilation. The respiratory rate will be titrated to control partial pressures of carbon dioxide, from allograft insertion to end of surgery

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient presenting for bilateral sequential lung transplantation

Exclusion criteria

Single lung transplantation or combined heart-lung procedure. Planned use of cardiopulmonary bypass - severe pulmonary hypertension (mean pulmoary artery pressure > 60 mmHg) or significant right ventricular dysfunction.

Outcome results