Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000933550
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Date results provided
1/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
How Intra-Abdominal Insufflation Affects Mechanical Power in Various Body Positions?
Scientific title
A Comparison of the Effect of Intra-abdominal Insufflation on Mechanical Power in Different Body Positions for Patients Undergoing Elective Laparoscopic Cholecystectomy
Secondary ID [1] 312322 0
none
Universal Trial Number (UTN)
U1111-1309-1353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventilator-associated lung injury 334076 0
Condition category
Condition code
Anaesthesiology 330751 330751 0 0
Other anaesthesiology
Surgery 330958 330958 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We conducted a prospective observational study after ethics committee approval in patients over 18 years of age and American Society of Anesthesiologists (ASA) 1, 2, and 3 class patients undergoing elective laparoscopic cholecystectomy. All patients (n:60) included in the study were intubated and ventilated using a Drager Perseus A500 mechanical ventilator. All patients independent of the study are ventilated with this ventilator. The patients were ventilated in volume controlled ventilation (VCV) mode with a tidal volume of 7 ml/ kg, PEEP of 5 mmHg, I:E ratio of 1:2, respiratory rate of 12/min, fresh gas flow of 4 l/min, and FiO2 of 40%. Measurements were taken after hemodynamic stability was achieved. In 4 different conditions; the supine position pre-insufflation (Condition 1), the reverse Trendelenburg position 15º pre-insufflation (Condition 2), the supine position post-insufflation (Condition 3) and, the reverse Trendelenburg position 15º post-insufflation (Condition 4) peak pressure and hemodynamic data were recorded. The measurements of the patients were taken in the routine positions used during laparoscopic cholecystectomy operations. No non-routine positions were applied, and all patients independent of the study underwent surgery in this position. No interventional procedure was performed, and only observations were made during position changes. The patients were observed within 20 minutes after intubation. Mechanical power was calculated using predefined formula. Changes in 4 conditions were compared. The effect of obesity on mechanical power was investigated because it may affect compliance.
Intervention code [1] 328796 0
Not applicable
Comparator / control treatment
Comparator: Supine pre-insufflation
Control group
Active

Outcomes
Primary outcome [1] 338512 0
Our composite primary outcome is to observe the change in mechanical power (MP) in different body positions before and after insufflation, as well as the change in MP of other positions compared to the initial position (supine pre-insufflation).
Timepoint [1] 338512 0
After intubation within 20 minutes
Secondary outcome [1] 436225 0
The effect of obesity on MP.
Timepoint [1] 436225 0
Baseline (after intubation), 10 minutes before and within the first 10 minutes of surgery

Eligibility
Key inclusion criteria
During the study period, patients over 18 years of age, ASA class 1, 2, and 3, who underwent elective laparoscopic cholecystectomy under general anaesthesia and non-depolarising neuromuscular blockade were included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients under 18 years of age, (2) those who had undergone lung surgery, (3) those with advanced lung disease, (4) emergency surgery and (5) patients who did not accept the study were excluded.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size was calculated using G-Power version 3.0. With an effect size of 0.2, an alpha error of 5%, and a power of 95% the required sample size were calculated as 55 participants, and 60 participants were included in the study. Data were analysed using SPSS statistical software (version 23.0; SPSS Inc., Chicago, IL, USA). As the sample size was medium (n=60), the Z-value between -3.29 and +3.29 in the skewness and kurtosis evaluation was considered a normal distribution to test normality. (Kim, H. Y. (2013)). Data showing normal distribution were analysed using parametric tests, and data not showing normal distribution were analysed using non-parametric tests. Mechanical power data (within subjects) recorded before and after abdominal insufflation in two different body positions were tested by repeated measures mixed model ANOVA. The test was then repeated by adding obesity (between subjects) to the model. The homogeneity of variances for the differences between levels of repeated measures in the dataset was tested using Mauchly's test of sphericity. In cases where Mauchly's test of sphericity was statistically significant (p< .05), the Greenhouse-Geisser (GG) correction was applied as the assumption of sphericity was not met. Bonferroni correction was applied to reduce type 1 error in pairwise comparisons. P value < .05 was considered statistically significant in all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
1/02/2023
Date of last data collection
Anticipated
Actual
1/02/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26373 0
Turkey
State/province [1] 26373 0

Funding & Sponsors
Funding source category [1] 316720 0
Hospital
Name [1] 316720 0
S.B.Ü. Tepecik Training and Research Hospital
Country [1] 316720 0
Turkey
Primary sponsor type
Hospital
Name
S.B.Ü. Tepecik Training and Research Hospital
Address
Country
Turkey
Secondary sponsor category [1] 318923 0
None
Name [1] 318923 0
Address [1] 318923 0
Country [1] 318923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315493 0
Ethics Committee for Non-interventional Studies of S.B.Ü. Tepecik Training and Research Hospital
Ethics committee address [1] 315493 0
Ethics committee country [1] 315493 0
Turkey
Date submitted for ethics approval [1] 315493 0
02/05/2022
Approval date [1] 315493 0
15/06/2022
Ethics approval number [1] 315493 0
decision number 2022/06-14.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134870 0
Dr BERNA SÖNMEZ
Address 134870 0
Sivasli Government Hospital, Evrenli, Ugur Mumcu cad. No: 147, 64800, Sivasli, Usak
Country 134870 0
Turkey
Phone 134870 0
+90 5363066011
Fax 134870 0
Email 134870 0
[email protected]
Contact person for public queries
Name 134871 0
BERNA SÖNMEZ
Address 134871 0
Sivasli Government Hospital, Evrenli, Ugur Mumcu cad. No: 147, 64800, Sivasli, Usak
Country 134871 0
Turkey
Phone 134871 0
+90 5363066011
Fax 134871 0
Email 134871 0
[email protected]
Contact person for scientific queries
Name 134872 0
BERNA SÖNMEZ
Address 134872 0
Sivasli Government Hospital, Evrenli, Ugur Mumcu cad. No: 147, 64800, Sivasli, Usak
Country 134872 0
Turkey
Phone 134872 0
+90 5363066011
Fax 134872 0
Email 134872 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


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.