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Trial registered on ANZCTR

Registration number

ACTRN12615000707561

Ethics application status

Approved

Date submitted

7/05/2015

Date registered

8/07/2015

Date last updated

1/03/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of a protective ventilation strategy in patients undergoing major neurosurgery: a pilot study

Scientific title

Safety and applicability of a protective ventilation strategy in patients undergoing neurosurgery, as compared to conventional mechanical ventilation.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1169-8923

Trial acronym

Low VT in neurosurgery

Linked study record

Health condition

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

Protective mechanical ventilation strategy

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The patient randomized in the intervention group will undergo to a protective mechanical ventilation strategy set as described: volume controlled ventilation mode with a Positive End-Expiratory pressure equal to 5 cmH2O, a tidal volume equal to 6 ml/kg of ideal body weight. The respiratory rate will be initially set at 16 breaths/min. After the induction of anesthesia and patient's intubation, and before the beginning of the surgery, a recruitment maneuver will be done applying a pressure to the airway opening equal to 30 cmH2O for a period of 25-30 seconds. Recruitment maneuvers will be done anytime the patient will be deconnected from the ventilator.
The treatment will be administered to patients until the end of the surgery and, afterwards, till patients will be awaken from of the anesthesia

Intervention code [1]

Treatment: Other

Comparator / control treatment

The patient randomized in the control group will undergo to a conventional ventilation strategy set as described: volume controlled ventilation mode with zero End-Expiratory pressure, a tidal volume equal to 10 ml/kg of ideal body weight. The respiratory rate will be initially set at 6-8 breaths/min, afterwards regulated according the endtidal carbon dioxide tension (35-40 mmHg).
The treatment will be administered to patients until the end of the surgery and, afterwards, till patients will be awaken from of the anesthesia.

Control group

Active

Outcomes

Primary outcome [1]

To evaluate if a protective ventilation strategy is safety (i.e. number of intraoperative complications like desaturation or hypotension) during a major neurosurgery

Timepoint [1]

Immediately at the completion of the surgery

Primary outcome [2]

To evaluate if a protective ventilation strategy is feasible (i.e. evaluation of the cerebral tension by the surgeon, possibility of optimal control of arterial carbon dioxide) during a major neurosurgery.

Timepoint [2]

Immediately at the completion of the surgery

Secondary outcome [1]

Number of pulmonary complications (i.e. post-operative hypoxaemia, pneumonia, need of non-invasive or invasive ventilatory support), as assesed through peripheral oxygenation, arterial blood gases and/or chest X-Ray after the surgery, need of oxygen or non-invasive ventilation or invasive ventilation.

Timepoint [1]

This endpoint will be daily assessed till the day of the patient's discharge (or to 30 days after the surgery)

Secondary outcome [2]

Number of extra-pulmonary complications (sepsis or septic shock), as assessed by the vital parameters and laboratory blood tests (white blood cell, c-reactive protein, procalcitonin, organ failures indexes)

Timepoint [2]

This endpoint will be daily assessed till the day of the patient discharge (or to 30 days after the surgery)

Secondary outcome [3]

Intensive Care Unit (ICU), Hospital and 30-day mortalities as assessed through hospital medical records and follow up

Timepoint [3]

The mortality will be assessed at: 1) ICU discharge (whenever the patient will be admitted to ICU), 2) at hospital discharge and 3) at 30 days after the surgery.

Secondary outcome [4]

Number of admission in Intensive Care Unit (ICU) (together with the reason of admission) as assessed through medical records

Timepoint [4]

Daily assessed till hospital discharge or 30 days after surgery max

Secondary outcome [5]

ICU length of stay as computed by the total number of days spent in ICU, as recorded by medical records (whenever a patient will be admitted for any reason)

Timepoint [5]

Daily assessed till hospital discharge

Secondary outcome [6]

Hospital length of stay, as computed by the total number of days from the hospital admission to discharge recorded on medical records

Timepoint [6]

Daily assessed till hospital discharge

Secondary outcome [7]

Impact of the ventilation strategy on the cerebral tension at the beginning of the surgery, as assessed by the surgeon through a dedicated 4-point rating scale, from 0 (i.e. no cerebral tension) to 4 (i.e. severe cerebral tension).

Timepoint [7]

Beginning of the surgery

Eligibility

Key inclusion criteria

All the patients meeting the following criteria will be eligible for the study: 1) age equal or greater than 18 years; 2) cerebral or spinal neurosurgery with an expected duration equal or greater than 4 hours, 3) risk index for pulmonary post-operative complications greater than 2; 4) no need for post-operative ICU.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded if meeting one or more of the following criteria: 1) mechanical ventilation in the previous 2 weeks 2) BMI equal or greater than 35 3) sepsis or acute rspiratory failure in the previous 2 weeks 4) emergent or urgent surgery 5) neuromuscular diseases 6) consent withdraw.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

The allocation of a patient in a group is done with sealed opaque envelopes.

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

Simple randomization using a randomisation table created by computer

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

A specific computation of the sample size is not feasible, since no previous studies regarding this topic during neurosurgery have been done. However, we believe that a total of 60 patients, 30 for each group, will be enough for a feasibility pilot study.
After data analysis, the normal distribution will be assessed by the Kolmogorov-Smirnov test. Data will be expressed as mean (standard deviation) or median [25-75 interquartile range], according to the normality test.
Data will be compared with Student t-test or Mann-Whitney U test or chi2 or Fisher’s exact test, as indicated.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/12/2014

Date of last participant enrolment

Anticipated

31/12/2015

Actual

16/12/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Novara

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Federico Longhini, MD

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee Novara

Ethics committee address [1]

Corso Mazzini 18, 28100, Novara

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

04/09/2014

Approval date [1]

21/10/2014

Ethics approval number [1]

134/14

Summary

Brief summary

Recently, Futier et al. found that the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization, as compared with a practice of nonprotective mechanical ventilation (N Engl J Med. 2013 Aug 1;369(5):428-37). Moreover, Severgnini et al. found that a protective ventilation strategy during abdominal surgery lasting more than 2 h improved respiratory function and reduced the modified Clinical Pulmonary Infection Score without affecting length of hospital stay (Anesthesiology. 2013 Jun;118(6):1307-21). However, to date no studies investigate the role of a protective ventilation strategy during neurosurgery.
The present pilot study aims to evaluate if a protective ventilation strategy is: 1) safety (i.e. number of intraopeartive complication like desaturation or hypootension) and 2) feasible (i.e. evaluation of the cerebral tension by the surgeon, possibility of optimal control of arterial carbon dioxide) during a major neurosurgery. 
Secondarily, the study aims to evaluate: 
1) if a protective ventilation strategy will translate into reduced number of pulmonary complications (i.e. post-operative hypoxaemia, pneumonia, need of non-invasive or invasive ventilatory support), as assesed through peripheral oxygenation, arterial blood gases and/or chest X-Ray after the surgery, need of oxygen or non-invasive ventilation or invasive ventilation, compared to conventional strategies;
2) if a protective ventilation strategy will translate into reduced number of extra-pulmonary complications (sepsis or septic shock), as assessed by the vital parameters and laboratory blood tests (white blood cell, c-reactive protein, procalcitonin, organ failures indexes), compared to conventional strategies;
3) the ICU, hospital and 30-days mortalities, as assessed through hospital medical records;
4) the number of admission in ICU (together with the reason of admission);
5) the ICU lenght of stay as computed by the total number of days spent in ICU (whenever a patient will be admitted for any reason);
6) the hospital lenght of stay, as computed by the total number of days  from the hospital admission to discharge;
7) the impact of the ventilation strategy on the cerebral tension at the beginning of the surgery, as assessed by the surgeon through a dedicated 4-point rating scale, from 0 (i.e. no cerebral tension) to 4 (i.e. severe cerebral tension).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+39 3475395967

Fax

longhini.federico@gmail.com

Contact person for public queries

Name

Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+39 3475395967

Fax

longhini.federico@gmail.com

Contact person for scientific queries

Name

Federico Longhini

Address

Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli

Country

Italy

Phone

+39 3475395967

Fax

longhini.federico@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial.	2021	https://dx.doi.org/10.1186/s12871-021-01404-8

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

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Documents added automatically