ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000298112

Ethics application status

Approved

Date submitted

21/01/2019

Date registered

27/02/2019

Date last updated

27/02/2019

Date data sharing statement initially provided

27/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of a lung recruitment strategy lung gas function during general anaesthesia

Scientific title

Effect of a lung recruitment strategy on ventilation-perfusion scatter and lung gas exchange during general anaesthesia

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

intraoperative lung atelectasis

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intraoperative stepped lung recruitment manoeuvre (stepped increases in PEEP [Positive End expiratory Pressure] of 5cmH2O from 0 up to 20cmH2O) using the Maquet Flow-i anaesthesia machine, applied by the anaesthetist after commencement of laparoscopic gas insufflation, with identification of optimal PEEP using monitoring of dynamic lung compliance, with continued ventilation at 6-8 mL/kg tidal volume and optimal PEEP + 2 cmH2O at a rate to mantain EtCO2 at 35-40 mmHg. Data will be logged automatically by the Flow-i and downloaded at the end of the case.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Standard intraoperative ventilation management using the Maquet Flow-i anaesthesia machine: 6-8 mL/kg tidal volume and PEEP 5 cmH2O at a rate to mantain EtCO2 at 35-40 mmHg

Control group

Active

Outcomes

Primary outcome [1]

Cumulative sevoflurane consumption, measured internally by the Flow-i anaesthesia machine

Timepoint [1]

At end of surgery

Secondary outcome [1]

Measured A-a gradient for PCO2 meaured from end-tidal gas monitoring and arterial blood gas sampling

Timepoint [1]

60 Minutes post commencement of laparoscopic gas insufflation

Secondary outcome [2]

FIO2/PaO2 ratio meaured from inspired gas monitoring and arterial blood gas sampling

Timepoint [2]

60 Minutes post commencement of laparoscopic gas insufflation

Secondary outcome [3]

Alveolar deadspace fraction calculated using the modified Bohr-Enghoff equation from end-tidal and arterial PCO2 measurements

Timepoint [3]

60 Minutes post commencement of laparoscopic gas insufflation

Secondary outcome [4]

Measured A/a ratio for sevoflurane, measured from monitored end-tidal waveform concentrations and in aretrial blood from sampling of 10 ML blood and headspace equilibration method.

Timepoint [4]

60 Minutes post commencement of laparoscopic gas insufflation

Secondary outcome [5]

Time to eye opening to command repeated every 30 seconds after cessation of fresh gas sevoflurane delivery, observed and recorded by the anaaesthetist

Timepoint [5]

At end of surgery

Eligibility

Key inclusion criteria

Patients undergoing elective laparoscopic bowel surgery under relaxant general anaesthesia planned to take at least 1 hour where placement of an arterial blood pressure monitoring line is considered appropriate for cardiovascular monitoring (systemic arterial blood pressure and/or cardiac output monitoring) for clinical purposes.

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients unable to provide informed consent
Women who are pregnant
Patients with cognitive impairment
Patients with poor command of English.
Body mass index (BMI) > 35.
Impaired lung function: Patients with severely impaired respiratory function on history and examination (FEV1 TLCO or FVC < 30% predicted),

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

22/01/2019

Date of last participant enrolment

Anticipated

31/12/2020

Actual

Date of last data collection

Anticipated

31/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Maquet Critical Care AB

Address [1]

Rontgenvagen 2
S-17155 Solna

Country [1]

Sweden

Primary sponsor type

Hospital

Name

Austin Health

Address

Studley Rd
Heidelberg
VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Research Ethics Committee

Ethics committee address [1]

Studley Rd
Heidelberg
VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/11/2018

Ethics approval number [1]

HREC/18/Austin/164

Summary

Brief summary

A major contributor to postoperative pulmonary complications after major surgery is collapse (atelectasis) in poorly ventilated lung segments during and after general anaesthesia (GA). Atelectasis arises from the reduced muscle tone caused by nearly all anaesthetics,and the non-physiological pattern of distribution of ventilation that characterizes controlled mechanical positive pressure ventilation (CMV), and occurs early in the course of anaesthesia.
Strategies to reduce lung atelectasis and postoperative pulmonary complications include the use of positive end-expiratory pressure (PEEP) and lung recruitment manoeuvres. 

Recently, Maquet Critical Care AB (Sweden) have released a new functionality on their Flow-i anaesthesia machine which allows targeted lung recruitment using a stepped increase in PEEP and lung inflation pressures. The system simultaneously monitors airway pressures and dynamic lung compliance, The latter is used to identify the optimal level of PEEP to minimize lung atelectasis, where measured dynamic lung compliance (Cdyn) is maximal.

We wish to measure the effectiveness of this new technology on improving lung function and gas exchange in patients under GA for elective surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Philip Peyton

Address

Dept of Anaesthesia
Austin Health
Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 94965000

Fax

[email protected]

Contact person for public queries

Name

Philip Peyton

Address

Dept of Anaesthesia
Austin Health
Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 94965000

Fax

[email protected]

Contact person for scientific queries

Name

Philip Peyton

Address

Dept of Anaesthesia
Austin Health
Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 94965000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data underlying published results

When will data be available (start and end dates)?

Beginning 6 months and ending 5 years following main results publication

Available to whom?

Researchers who provide a methodologically sound proposal, at the discretion of the Chief Investigator

Available for what types of analyses?

To achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator, with requirement to sign data access agreement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Peyton PJ, Aitken S, Wallin M. Effects of an open ... [More Details]	376792-(Uploaded-21-12-2021-18-00-50)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of an open lung ventilatory strategy on lung gas exchange during laparoscopic surgery.	2022	https://dx.doi.org/10.1177/0310057X211047602

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically