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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] 286667 0
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 295007 0
Condition category
Condition code
Anaesthesiology 295269 295269 0 0
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] 291818 0
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] 295017 0
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] 295017 0
Immediately at the completion of the surgery
Primary outcome [2] 295257 0
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] 295257 0
Immediately at the completion of the surgery
Secondary outcome [1] 314584 0
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] 314584 0
This endpoint will be daily assessed till the day of the patient's discharge (or to 30 days after the surgery)
Secondary outcome [2] 315203 0
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] 315203 0
This endpoint will be daily assessed till the day of the patient discharge (or to 30 days after the surgery)
Secondary outcome [3] 315204 0
Intensive Care Unit (ICU), Hospital and 30-day mortalities as assessed through hospital medical records and follow up
Timepoint [3] 315204 0
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] 315424 0
Number of admission in Intensive Care Unit (ICU) (together with the reason of admission) as assessed through medical records
Timepoint [4] 315424 0
Daily assessed till hospital discharge or 30 days after surgery max
Secondary outcome [5] 315425 0
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] 315425 0
Daily assessed till hospital discharge
Secondary outcome [6] 315426 0
Hospital length of stay, as computed by the total number of days from the hospital admission to discharge recorded on medical records
Timepoint [6] 315426 0
Daily assessed till hospital discharge
Secondary outcome [7] 315427 0
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] 315427 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6868 0
Italy
State/province [1] 6868 0
Novara

Funding & Sponsors
Funding source category [1] 291247 0
Self funded/Unfunded
Name [1] 291247 0
Address [1] 291247 0
Country [1] 291247 0
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] 289922 0
None
Name [1] 289922 0
Address [1] 289922 0
Country [1] 289922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292807 0
Ethical Committee Novara
Ethics committee address [1] 292807 0
Corso Mazzini 18, 28100, Novara
Ethics committee country [1] 292807 0
Italy
Date submitted for ethics approval [1] 292807 0
04/09/2014
Approval date [1] 292807 0
21/10/2014
Ethics approval number [1] 292807 0
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 57110 0
Dr Federico Longhini
Address 57110 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 57110 0
Italy
Phone 57110 0
+39 3475395967
Fax 57110 0
Email 57110 0
longhini.federico@gmail.com
Contact person for public queries
Name 57111 0
Dr Federico Longhini
Address 57111 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 57111 0
Italy
Phone 57111 0
+39 3475395967
Fax 57111 0
Email 57111 0
longhini.federico@gmail.com
Contact person for scientific queries
Name 57112 0
Dr Federico Longhini
Address 57112 0
Intensive Care Unit, ASL VC - Azienda Sanitaria Locale di Vercelli, C.so Mario Abbiate n. 21 - 13100 - Vercelli
Country 57112 0
Italy
Phone 57112 0
+39 3475395967
Fax 57112 0
Email 57112 0
longhini.federico@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary