Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000912088
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
26/10/2010
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of respiratory mechanics according to tidal volume obtained from predicted, current estimated and no body weight prediction method in patients under pressure controlled mechanical ventilation.
Scientific title
Do differences of tidal volume, calculated from predicted, current estimated and no body weight prediction method, change the respiratory mechanics of patients under pressure controlled mechanical ventilation?
Secondary ID [1] 252871 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory failure. 258391 0
Inappropriate tidal volume during pulmonary mechanical ventilation 258392 0
Condition category
Condition code
Respiratory 258563 258563 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the calculation will be done for every participant. Each phase correspond to one of the three interventions. Each phase will be performed once over a single day.
PHASE 1: calculation of predicted body weight through the formulas:50+0,91(height in centimeters)-152,4 for men and 45,5 +0,91 (height in centimeters)-152,4 for women. The result will be multiplied by 6 ml (this is the ARDS recommendation of protective ventilation) and the final result will be the tidal volume. We'll adjust the pressure limit that offers this tidal volume and keep the ventilation for 2 hours. After, the respiratory mechanics will be calculated according to the found tidal volume.
PHASE 2: calculation of the current estimated body weight through the formula: [0,98 X calf circumference(cm) + 1,16 X knee height(cm)]+[1,73 X arm circumference (cm)]+0,37 X subscapularis skinfold(mm)]-81,69 for men and [1,27 X calf ircumference(cm)]+[0,87 X knee height(cm)]+0,98 X arm circumference (cm)]+0,4 X subscapularis skinfold(cm)]-62 for women. The result will be multiplied by 6 ml and the final result will be the tidal volume. We'll adjust the pressure limit that offers this tidal volume and keep the ventilation for 2 hours. After, the respiratory mechanics will be calculated according to the found tidal volume.
PHASE 3: for no body weight prediction method we'll use the tidal volume observed at the mechanical ventilator initially. After, the respiratory mechanics will be calculated according to this tidal volume. Then the results of respiratory mechanics corresponding to each phase will be compared and defined which prediction body weight method is more appropriate, closer to normal values os respiratory mechanics.
Intervention code [1] 257396 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259411 0
Alteration of respiratory mechanics (pulmonary static compliance, pulmonary dynamic compliance and resistance).
Timepoint [1] 259411 0
After the application of tidal volumes corresponding to each calculated weight.
Secondary outcome [1] 265952 0
Which tidal volume can avoid acute lung injury.
Timepoint [1] 265952 0
After 2 hours of mechanical ventilation.

Eligibility
Key inclusion criteria
Adult patients, patients under mechanical ventilation, pressure controlled mode, respiratory failure diagnosed, hemodynamically stable patients, sedated patients.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other ventilatory mode, sepsis diagnosed, presence of respiratory drive.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2972 0
Brazil
State/province [1] 2972 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 257833 0
University
Name [1] 257833 0
Universidade Federal do Triangulo Mineiro
Country [1] 257833 0
Brazil
Primary sponsor type
Individual
Name
Lilane Maria Alves Silva
Address
Rua: Dona Rafa Cecilio, 259
Vila Maria Helena
Cep: 38020-080
Uberaba - Minas Gerais
Country
Brazil
Secondary sponsor category [1] 257035 0
Individual
Name [1] 257035 0
Taciane Cristina Santana
Address [1] 257035 0
Rua: Joao Pessoa n.280
Bairro: Abadia
Cep: 38025-400
Uberaba - Minas Gerais
Country [1] 257035 0
Brazil
Other collaborator category [1] 251557 0
Hospital
Name [1] 251557 0
Hospital de Clinicas da Universidade Federal do Triangulo Mineiro
Address [1] 251557 0
Avenida Getulio Guarita n.130
Bairro Abadia
Cep: 38025-440
Uberaba - Minas Gerais
Country [1] 251557 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259862 0
Comite de Etica em Pesquisa da Universidade Federal do Triangulo Mineiro
Ethics committee address [1] 259862 0
Avenida Frei Paulino, 30 2 andar, Sala H Abadia
Cep: 38025-180 - Uberaba - Minas Gerais
Ethics committee country [1] 259862 0
Brazil
Date submitted for ethics approval [1] 259862 0
26/09/2008
Approval date [1] 259862 0
08/12/2008
Ethics approval number [1] 259862 0
1226

Summary
Brief summary
The Acute Respiratory Distress Syndrome Group (ARDS) determines that we must use 6 ml of kg of predicted body weight in order to offer appropriate measures of tidal volume to patients under mechanical ventilation. But improper methods to predict the body weight may cause damage to patients' lungs. Inadequate tidal volume will reflect in respiratory mechanics alteration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31771 0
Dr Lilane Maria Alves Silva
Address 31771 0
Universidade Federal do Triangulo Mineiro
Av. Getulio Guarita, 130 Bairro Abadia Uberaba, Minas Gerais, Brazil
cep 38025-440
Country 31771 0
Brazil
Phone 31771 0
+553433185000
Fax 31771 0
Email 31771 0
[email protected]
Contact person for public queries
Name 15018 0
Dr Lilane Maria Alves Silva
Address 15018 0
Universidade Federal do Triangulo Mineiro
Av. Getulio Guarita, 130 Bairro Abadia Uberaba, Minas Gerais, Brazil
cep 38025-440
Country 15018 0
Brazil
Phone 15018 0
+553433185000
Fax 15018 0
Email 15018 0
[email protected]
Contact person for scientific queries
Name 5946 0
Dr Lilane Maria Alves Silva
Address 5946 0
Universidade Federal do Triangulo Mineiro
Av. Getulio Guarita, 130 Bairro Abadia Uberaba, Minas Gerais, Brazil
cep 38025-440
Country 5946 0
Brazil
Phone 5946 0
+553433185000
Fax 5946 0
Email 5946 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
withdrawn


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
No additional documents have been identified.