Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000754347
Ethics application status
Approved
Date submitted
25/04/2017
Date registered
22/05/2017
Date last updated
14/03/2019
Date data sharing statement initially provided
14/03/2019
Date results information initially provided
14/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Influence of Different Breathing Modes on Oxygenation in a Lung Ventilation
Scientific title
Effect of Pressure-Controlled Ventilation-Volume Guaranteed on Respiratory Dynamics and Oxygenation in One-Lung Ventilation: A Prospective, Randomized-Controlled Study
Secondary ID [1] 291772 0
None
Universal Trial Number (UTN)
U1111-1195-9172
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
One lung ventilation 302996 0
Condition category
Condition code
Anaesthesiology 302459 302459 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hypoxemia may develop in some patients, although one-lung ventilation (OLV) can be safely implemented to expand the field of vision and to facilitate surgical manipulation during lung surgeries. The main cause of hypoxemia is pulmonary shunt due to a single non-ventilated lung. Volume-controlled ventilation (VCV) is usually used as a mechanical ventilation modes, when OLV is implemented. Increased airway pressures in the ventilated lung cause the blood flow to be directed to the non-ventilated lung and the rate of pulmonary shunts further increases, thereby, leading to a deepening of hypoxemia. On the other hand, pressure-controlled ventilation-volume guaranteed (PC-VG) ventilation mode is used as a preventive ventilatory strategy during acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), and prevents uncontrolled increase in the alveolar pressure. Several studies comparing PC-VG with VCV have demonstrated that PC mode reduces the airway pressure and improves the partial arterial oxygen pressure (PaO2), particularly in patients with low preoperative forced vital capacity (FVC) values. In addition, the peak airway pressure (Ppeak) has been shown to decrease, while PaO2 increases due to decreased inspiratory current in the PC mode during ALI and ARDS. Therefore, the PC mode has been suggested to be an alternative ventilation mode to avoid high airway pressures during OLV In pressure-controlled ventilation-volume guaranteed (PC-VG) mode,

The patients were provided with mechanical ventilatory support (Datex-Ohmeda Avance Anesthesia Machine, GE Healthcare, Madison WI USA) at a tidal volume of 7 mL/kg with 4 PEEP support to achieve an inspiration/expiration ratio of 1:2 and 50% FiO2.. During One lung ventilation (OLV), the tidal volumes of patients were reduced to 4 mL/kg and the respiratory frequency was increased up to 18-20. In the case of intraoperative hypoxia (Patients will be evaluated by the same consultant anaesthetist), certain maneuvers were performed for patient optimization including re-adjustment of tidal volume, increasing oxygen ratio, increasing PEEP, oxygen insufflation in non-ventilated lungs, fiberoptic confirmation of location of the intubation tube, and intermittent two-lung ventilation. The patients in PC-VG mode will monitored using the same mechanical ventilation mode from induction of anaesthesia to end of procedure.
Intervention code [1] 297881 0
Treatment: Devices
Comparator / control treatment
In Volume-controlled ventilation mode, the patients were provided with mechanical ventilatory support (Datex-Ohmeda Avance Anesthesia Machine, GE Healthcare, Madison WI USA) at a tidal volume of 7 mL/kg with 4 PEEP support to achieve an inspiration/expiration ratio of 1:2 and 50% FiO2. During OLV, the tidal volumes of patients were reduced to 4 mL/kg and the respiratory frequency was increased up to 18-20. The patients in VG mode will monitored using the same mechanical ventilation mode from induction of anaesthesia to end of procedure.
Control group
Active

Outcomes
Primary outcome [1] 301875 0
The effect of pressure-controlled ventilation-volume guaranteed on arterial blood gas values
Timepoint [1] 301875 0
At baseline (post intubation), and 15 and 60 mins of OLV, at 15 mins of TLV after lobectomy, and postoperative 6th and 24th-hour (arterial blood gas analysis will be used)
Primary outcome [2] 302102 0
peak inspiratory pressure (PIP)
Timepoint [2] 302102 0
At baseline (post intubation), 15th and 60th min OLV, and 15 min after TLV following lobectomy were recorded.
(Airway pressure monitoring, Datex-Ohmeda Avance Anesthesia Machine, GE Healthcare, Madison WI USA)
Primary outcome [3] 302103 0
hemodynamic parameters (Mean arterial pressure, heart rate, CVP)
Timepoint [3] 302103 0
At baseline, and 15 and 60 mins of OLV, at 15 mins of TLV after lobectomy, and postoperative 6th and 24th-hour (invasive arterial pressure, central venous pressure, pulse oximetry, ECG on hemodynamic monitor)
Secondary outcome [1] 334170 0
complications in one lung ventilation: Complications were defined as follows;
1. Cardiac complications: Postoperative myocardial infarction, atrial or ventricular arrhythmias damaging hemodynamics,
2. Respiratory complications: Evaluated as Pneumonia, reintubation, tracheotomy, PaO2 values under 60%, PaCO2 values over 45 mmHg, Acute respiratory deficiency syndrome (ARDS);
3. Cerebrovascular Events: Stroke, temporal ischemic attack, cerebral hemorrhage, infarct;
4. Renal Dysfunction: 0,5 mg dl-2 increase in creatinine when compared to basal values or 50% decrease in the calculated clearance rate or a need for renal replacement treatment/dialysis;
5. Gastrointestinal Complications: Ileus, abdominal distension, mesenteric ischemia,
6. Hematologic Complications: Massive transfusion, thrombocytopenia, hemolysis, disseminated intravascular coagulation (DIC)
7. Infection and Sepsis: Proven infection and accompanying systemic inflammatory response syndrome.
8. Multiple Organ Dysfunction (MODS): Dysfunction of two or more organs
9. Need for Reoperation: A need for revision due to bleeding or for any other reason

Timepoint [1] 334170 0
30 days post treatment

Eligibility
Key inclusion criteria
Lung lobectomy patients (Only lung lobectomy under one lung ventilation)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they had renal, cardiac, hepatic impairment; a body mass index greater than 30 kg/m2, and defined as less than 50% of the predicted values of forced expiratory volume in 1 second and forced vital capacity.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis was performed using the SPSS version 21.0 software (IBM Corp., Armonk, NY, USA) data were expressed in mean±standard deviation (SD), mean, and percentage (%). Normal distribution of data was analyzed using the Kolmogorov-Smirnov test. The chi-square and Fisher Exact tests were used for categorical variables, whereas the independent-samples t-test and Mann-Whitney U test were used for quantitative variables. A p value of <0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/07/2016
Date of last participant enrolment
Anticipated
Actual
28/02/2017
Date of last data collection
Anticipated
Actual
10/03/2017
Sample size
Target
80
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 8844 0
Turkey
State/province [1] 8844 0

Funding & Sponsors
Funding source category [1] 296276 0
Self funded/Unfunded
Name [1] 296276 0
Cengiz Sahutoglu
Country [1] 296276 0
Turkey
Primary sponsor type
Individual
Name
Cengiz sahutoglu
Address
Ege Universitesi Tip Fakultesi Anesteziyoloji ve Reanimasyon Anabilim Dali 35100, Bornova/Izmir
Country
Turkey
Secondary sponsor category [1] 295190 0
None
Name [1] 295190 0
Address [1] 295190 0
Country [1] 295190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297509 0
Ege University School of Medicine Clinical Research Ethical Committee
Ethics committee address [1] 297509 0
Ege University, Faculty of Medicine. Department of Medical Ethics & History of Medicine 35100, Bornova/ Izmir
Ethics committee country [1] 297509 0
Turkey
Date submitted for ethics approval [1] 297509 0
31/05/2016
Approval date [1] 297509 0
16/07/2016
Ethics approval number [1] 297509 0
16-7/35

Summary
Brief summary
The aim of this study was to investigate the effects of pressure-controlled ventilation-volume guaranteed (PC-VG) and volume-controlled ventilation (VCV) mode on respiratory parameters (intraoperative and postoperative) and complications in patients with one-lung ventilation (OLV) who underwent lobectomy.
This prospective, randomized-controlled study included a total of 80 patients who underwent one-lung ventilation and lobectomy between July 2016 and February 2017. The patients were randomly divided into two groups as Group 1 (PC-VG) and Group 2 (VCV). Data including demographic characteristics of the patients, intraoperative mechanical ventilation parameters, intraoperative and postoperative oxygenation parameters, and complications were recorded. Two ventilation modes were compared.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74266 0
Dr Cengiz Sahutoglu
Address 74266 0
Ege Universitesi Tip Fakultesi Anesteziyoloji ve Reanimasyon Anabilim Dali 35100, Bornova/Izmir
Country 74266 0
Turkey
Phone 74266 0
+902323902143
Fax 74266 0
Email 74266 0
cengiz.sahutoglu@ege.edu.tr
Contact person for public queries
Name 74267 0
Dr Cengiz Sahutoglu
Address 74267 0
Ege Universitesi Tip Fakultesi Anesteziyoloji ve Reanimasyon Anabilim Dali 35100, Bornova/Izmir
Country 74267 0
Turkey
Phone 74267 0
+902323902143
Fax 74267 0
Email 74267 0
cengiz.sahutoglu@ege.edu.tr
Contact person for scientific queries
Name 74268 0
Dr Cengiz Sahutoglu
Address 74268 0
Ege Universitesi Tip Fakultesi Anesteziyoloji ve Reanimasyon Anabilim Dali 35100, Bornova/Izmir
Country 74268 0
Turkey
Phone 74268 0
+902323902143
Fax 74268 0
Email 74268 0
cengiz.sahutoglu@ege.edu.tr

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
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Int J Clin Exp Med 2018;11(12):13681-13688. 372802-(Uploaded-08-03-2019-00-04-26)-Journal results publication.pdf

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
344Study results articleYes Int J Clin Exp Med 2018;11(12):13681-13688. 372802-(Uploaded-08-03-2019-00-04-26)-Journal results publication.pdf
2968Plain language summaryNo Ninety-eight patients were enrolled in the study, ... [More Details]

Documents added automatically
No additional documents have been identified.