Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001191684
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
12/11/2014
Date last updated
12/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of positive end-expiratory pressure at different levels on postoperative respiration parameters in patients undergoing laparoscopic cholecystectomy
Scientific title
The effects of positive end-expiratory pressure at different levels (0, 5 and 8 cmH2O) on postoperative respiration parameters in patients undergoing laparoscopic cholecystectomy
Secondary ID [1] 285502 0
None
Universal Trial Number (UTN)
U1111-1162-9238
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative respiration parameters following cholecystectomy 293296 0
Condition category
Condition code
Respiratory 293566 293566 0 0
Normal development and function of the respiratory system
Surgery 293567 293567 0 0
Other surgery
Anaesthesiology 293568 293568 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From June 2013 to March 2014, 105 consecutive patients undergoing elective laparoscopic cholecystectomy were included in this study. Preoperatively, physical examination of the patients was performed by an anaesthesiologist and all patients received detailed information about the respiratory function test and spirometry. Before the operation, respiratory function was evaluated using spirometry (Vitalograph micro. 63000 Series, Ennis, Ireland) by an anaesthesiologist blinded to the group assignment. Before entering the operating room, all patients received 500 mL of colloids via intravenous (IV) cannula and premedication was provided with intramuscular (im) 0.1 mg/kg midazolam for all patients before induction of anaesthesia. Standard monitoring including non-invasive arterial pressure, electrocardiography and pulse oximetry was established in the operating room. Before the operation, heart rate (HR), peripheral oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) values were recorded. Patients were randomly allocated into one of the three groups after induction of general anaesthesia using a computer generated random number table. Group I (n=35) did not receive PEEP whereas group II (n=35) received PEEP as 5 cmH2O and group III received PEEP as 8 cm H2O in mechanical ventilation during laparoscopic procedure . Same anaesthesia protocol was applied for all patients. Anaesthesia induction was provided with IV 2. microg/kg fentanyl, IV 2mg/kg propofol and 0.5-1 mg/kg rocuronium. All patients received colloids at a rate of 3-5 ml/kg/h during operation. Tracheal intubation was performed and anaesthesia was maintained with sevoflurane 1-2%, air (50%), oxygen (50%) and remifentanyl infusion at a rate of 0.15-0.25 microg/kg/min. During anaesthesia, all patients were ventilated with a Datex- Ohmeda anaesthetic machine (Madison WI 53707, USA). The ventilator mode was standardized in all patients (tidal volume of 8ml/kg, a respiratory rate of 12 bpm and I:E time = 1:2). The patients' ventilatory parameters were set to maintain a goal end-tidal carbon dioxide between 30-35 mmHg. In addition to basic ventilation settings, patients in group I did not receive PEEP, patients in group II received PEEP as 5 cmH2O and patients in group III received PEEP as 8 cmH2O in mechanical ventilation during laparoscopic procedure. While the patient was in the supine position, the abdominal cavity was inflated with CO2, the intra-abdominal pressure did not exceed 12 mmHg. Patient was then enrolled in trendelenburg position and the same position was maintained during operation. Intra-abdominal pressure was kept at 12-15 mmHg automatically during surgery.After the completion of surgery, remifentanyl infusion was stopped; lungs were ventilated with 100% O2 manually until the spontaneous respiration was observed. Neuromuscular block was reserved with neostigmine (0.04 mg kg-1, IV) and atropine (0.02 mg kg-1, IV). After sufficient muscle strength was obtained, extubation was carried out. After extubation, all patients were transferred to the recovery room. All patients received standard postoperative care. Postoperative analgesia was provided with tramadol 1mg/kg, IV (Contramal, Abdi Ibrahim, Turkey) and postoperative nausea-vomiting was treated with metoclopramide in all patients. The patients with Aldrete score above 8 were transferred to the service. Measurements with spirometry were taken 1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation by an anaesthetist blinded to intraoperative group assignment. All measurements were performed in upright sitting position according to the American Thoracic Society guidelines. All measurements were only performed while patients had a pain score at rest under 4 (0, no pain; 10, maximum pain). The test was ended when the patient got tired or did not want to go on the test or a failure occurred, although it was repeated mostly 8 times. Forced expiratory volume (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) were measured three times at each time point and highest values were recorded for analysis. Socio-demographic characteristics of the patients (age, gender, weight, height and BMI) and HR, SpO2, SBP, DBP and MAP parameters at each time point were also recorded.
Intervention code [1] 290442 0
Treatment: Devices
Comparator / control treatment
Control group: Patients applied 0 cmH2O positive end-expiratory pressure in mechanical ventilation (PEEP)
Control group
Dose comparison

Outcomes
Primary outcome [1] 293380 0
to evaluate postoperative respiration parameters including forced expiratory volume (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) using spirometer in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications.
Timepoint [1] 293380 0
Timepoint:1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation
Secondary outcome [1] 310891 0
to evaluate postoperative heart rate (HR) changes using electrocardiography in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications.
Timepoint [1] 310891 0
1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation
Secondary outcome [2] 311096 0
to evaluate peripheral oxygen saturation (SpO2) changes using pulse oximetry in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications.
Timepoint [2] 311096 0
1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation
Secondary outcome [3] 311097 0
to evaluate mean arterial pressure (MAP) values using standard monitorization in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications.
Timepoint [3] 311097 0
1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation

Eligibility
Key inclusion criteria
105 consecutive patients, with American Society of Anesthesiologists (ASA) physical status I or II, aged 18-65 years undergoing elective laparoscopic cholecystectomy were included in this study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with ASA III-V physical status, smoking, body mass indexes (BMI) > 40 kg/m2, cardiorespiratory disease and unable to perform pulmonary function tests were excluded from the study

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data were analysed using SPSS software 12.0 (SPSS Inc., Chicago, IL, USA) and calculated as mean +/- standard deviation, P < 0.05 was considered significant. The Kolmogorov-Smirnov test was used to assess the normal distribution of data. Independent paired sample t test was used to compare intergroup measures (age, weight, BMI, HR, SpO2, SBP, DBP, MAP, FEV1, FVC and PEF values). Intragroup differences were researched using Bonferroni test following the one-way analysis of variance (One-Way ANOVA). Sample size was calculated as minimum 28 patients per group , based on our preliminary results to detect a minimum difference of 0.21 L in the FEV1 parameter among groups with a power of 80%, alpha of 0.05 and beta of 0.20. However, we selected 105 participants to improve the chances of accuracy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2013
Actual
10/06/2013
Date of last participant enrolment
Anticipated
31/03/2014
Actual
31/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 6424 0
Turkey
State/province [1] 6424 0
Erzurum

Funding & Sponsors
Funding source category [1] 290101 0
Self funded/Unfunded
Name [1] 290101 0
Dr. Mehmet AKSOY
Country [1] 290101 0
Turkey
Primary sponsor type
Individual
Name
Mehmet Aksoy
Address
Dr. Mehmet AKSOY
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Vaniefendi district, Ataturk University, Erzurum, Turkey Postal code: 25240
Country
Turkey
Secondary sponsor category [1] 288807 0
Individual
Name [1] 288807 0
Bahadir Ciftci
Address [1] 288807 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Vaniefendi district, Ataturk University, Erzurum, Turkey Postal code: 25240
Country [1] 288807 0
Turkey
Secondary sponsor category [2] 288808 0
Individual
Name [2] 288808 0
Ilker Ince
Address [2] 288808 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Vaniefendi district, Ataturk University, Erzurum, Turkey Postal code: 25240
Country [2] 288808 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291809 0
Ataturk University Medical Faculty Ethical Committee, Erzurum,Turkey
Ethics committee address [1] 291809 0
Ethics committee country [1] 291809 0
Turkey
Date submitted for ethics approval [1] 291809 0
01/05/2013
Approval date [1] 291809 0
06/06/2013
Ethics approval number [1] 291809 0

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

Contacts
Principal investigator
Name 52118 0
Dr Mehmet Aksoy
Address 52118 0
Dr. Mehmet AKSOY
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Vaniefendi district, Ataturk University, Erzurum, Turkey Postal code: 25240
Country 52118 0
Turkey
Phone 52118 0
+90 505 819 35 26
Fax 52118 0
+90 442 236 09 68
Email 52118 0
[email protected]
Contact person for public queries
Name 52119 0
Ilker Ince
Address 52119 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Vaniefendi district, Ataturk University, Erzurum, Turkey Postal code: 25240
Country 52119 0
Turkey
Phone 52119 0
+9 0507 243 75 47
Fax 52119 0
+90 442 236 09 68
Email 52119 0
[email protected]
Contact person for scientific queries
Name 52120 0
Mehmet Aksoy
Address 52120 0
Department of Anaesthesiology and Reanimation, Faculty of Medicine, Vaniefendi district, Ataturk University, Erzurum, Turkey Postal code: 25240
Country 52120 0
Turkey
Phone 52120 0
+90 505 819 35 26
Fax 52120 0
+90 442 236 09 68
Email 52120 0
[email protected]

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Results publications and other study-related documents

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