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AzTrials

Lung DiseasesPhase 3NCT01763879

Pressure-controlled vs Volume Controlled Ventilation on RV Function During OLV

A Phase 3 study testing The PCV-VCV group and The VCV-PCV group in people with Lung Diseases, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for thoracic surgery is associated with comparable oxygenation with volume controlled ventilation (VCV) with added benefits of decreasing airway pressures and shunt fraction. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lung Diseases
What is being tested?
The PCV-VCV group and The VCV-PCV group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSaudi Arabia
Study dates
Apr 2012to Mar 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical class from II to III

Who cannot join

  • decompensated cardiac (New York Heart Association >II)
  • pulmonary (vital capacity or FEV1% < 50% of the predicted values)
  • asthma
  • hepatic diseases.
  • renal diseases
  • arrhythmias
Show all 9Show fewer
  • pulmonary hypertension (mean pulmonary artery pressure >30 mm Hg)
  • body mass index >35 kg/m2
  • previous history of pneumonectomy, bilobectomy, or lobectomy

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Anesthesiology Department

    Khobar, Eastern Province, 31592

Other trials in Saudi Arabia

About this study

Official title: Right Ventricular Function During One-lung Ventilation: The Effects of Pressure Controlled and Volume Controlled Ventilation

The use of pressure controlled ventilation (TV) during one lung ventilation (OLV) for thoracic surgery is associated with comparable oxygenation with volume controlled ventilation (VCV) with added benefits of decreasing airway pressures and shunt fraction. The later may improve the right ventricular (RV) function during OLV. We postulate that the use of PCV during OLV for thoracic surgery would preserve RV function than during VCV. After local ethics committee approval and informed consent, we will randomly allocate 28 patients scheduled for elective thoracic surgery OLV to randomly crossed from PCV to VCV mode (n= 14 for each) during with VT of 6 mL/kg, I: E ratio 1: 2.5, PEEP of 5 cm H2O, recruitment maneuvers and respiratory rate will be adjusted to maintain normocapnia. Intraoperative changes in the right ventricular function (peak systolic and diastolic tricuspid annular velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area changes (RV-FAC)), hemodynamic and oxygenation parameters, peak and plateau airway pressures, compliance will be recorded.

Read the detailed description

One-lung ventilation (OLV) provides excellent operative field for thoracic procedures, but is opposed by the harmful impairment of cardiac index and right ventricular (RV) function which may influence postoperative morbidity and mortality. In our previous study, we demonstrated significant reductions in RV ejection fraction (REF) and CI values after the initiation of OLV attributable to the increased right ventricular afterload, stroke work and end-diastolic volume augmented by increased airway pressures. This may be harmful with the patients with advanced obstructive lung diseases and those with pulmonary hypertension. Thus there is no doubt that decreases in airway pressures will be associated with better RV function.

Volume controlled ventilation (VCV) is the commonly used traditional ventilation mode for OLV during thoracic procedures but its use is associated with deleterious increases in airway pressure which may impede RV function.

Pressure controlled ventilation (PCV) is an alternative mode of ventilation which is widely used in the patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI), whereby high initial flow rates are delivered to quickly achieve and maintain the set inspiratory pressure followed by rapidly decelerating flow.These high initial flow rates lead to a more rapid alveolar inflation.

PCV has been suggested as a useful tool to improve oxygenation as well as decreases in intra-pulmonary shunt (Qs/Qt) and airway pressures compared with VCV during OLV for patients undergoing thoracic surgery. Whereas, others demonstrated comparable arterial oxygenation with the use of PCV and VCV during OLV.

However, the use of PCV offers advantages over VCV during OLV in the term of reducing mean and bronchial peak airway pressures and intrapulmonary shunt, hence limiting the risk for barotrauma and impaired RV function.

Up to the investigators knowledge, there is no available study of the effects of PCV and VCV on RV function during OLV after thoracic surgery.

The investigators hypothesize that the use of PCV during OLV will be associated with preserved RV function than during the use of VCV. They will compare the effects of the use of PCV and VCV with 5 cm H2O level of PEEP and recruitment maneuvers during OLV on the right ventricular function (peak systolic and diastolic tricuspid annular velocity (TAV), end-diastolic volume (EDV), end-systolic volume (ESV), and RV fractional area changes (RV-FAC)), hemodynamic parameters (heart rate (HR), mean arterial blood pressure, (MAP)), oxygenation parameters (arterial oxygen and carbon dioxide tension (PaO2 and PaCO2, respectively), and arterial tension to inspired fraction of oxygen (PaO2/FiO2) ratio), ventilation parameters (peak and plateau airway pressures (Ppk and Ppl, respectively) and compliance) and the ICU and hospital length-of-stays, morbidity and 30-day mortality.

Sample size calculation:

A priori power analysis of the previous published data11 showed that the investigators will need to study 13 pairs to detect a 20% difference in the mean maximal systolic TAV values (7.0 cm/s) with a SD of 1.4 cm/s, after start of OLV, a type-I error of 0.05 and a power of 90%. We will add 10% more patients for a final sample size of 28 patients to account for patients dropping out during the study.

Interventions:

In all patients, standard monitors will be applied. A thoracic epidural or paravertebral catheter will be inserted with no more use of local anesthetics during the study to avoid their effects on hypoxic pulmonary vasoconstriction.12 An arterial line (20 G) and a right internal jugular vein catheter will be inserted. Anesthetic technique will be standardized in all studied patients. Anesthesiologists who will give the anaesthetic will be not involved in the patient's assessment. General anesthesia will be induced with propofol (2-3 mg/kg), fentanyl (2-3 µg/kg), and cisatracurium (0.2 mg/kg) will be given to facilitate tracheal intubation with a left-sided double-lumen tube (DLT). The correct position of its tip will be confirmed with a fiberoptic bronchoscope. Anesthesia will be maintained with 1-1.5 minimum alveolar concentration (MAC) of sevoflurane and increments of fentanyl (0.5µg/kg) and cisatracurium (0.04 mg/kg).

The patients' lungs will be mechanically ventilated using VCV mode, fraction of inspired oxygen (FiO2) of 0.5 in air, tidal volume (VT) of 8 mL/kg (predicted body weight), inspiratory to expiratory [I: E] ratio of 1:2.5, a positive end-expiratory pressure (PEEP) of 5 cm H2O, respiratory rate (R.R) will be adjusted to achieve an PaCO2 of 35-45 mm Hg, peak inspiratory pressures (Ppk) will be limited to 35 cm H2O and a low fresh gas flow (FGF) (<2 L/min) in a semi closed circuit system.

Transesophageal echocardiography (TEE) will be inserted and the right ventricular function will be assessed with the measurements of EDV, ESV, RVEF, both maximal systolic and diastolic TAV at the tricuspid annulus at the RV free wall recorded from the apical 4-chamber views using pulsed wave Doppler tissue imaging.

All operations will be performed by the same surgeons. Intraoperative hypoxemia will be defined as decrease in arterial oxygen saturation less than 90% will be treated with increasing of FiO2 to 1.0. Addition of low level of 2 cm H2O of CPAP will be considered if the later fails to correct hypoxemia. 1 Intraoperative fluid therapy will include intravenous infusion of 2 ml/kg/hour of Lactated Ringer's solution and blood losses will be compensated with colloids and with red blood cell concentrates if the hemoglobin levels decreases below 8 to 9 g/dL. Mean arterial blood pressure will be maintained greater than 60 mm Hg using bolus doses of ephedrine 5 mg or phenylephrine 100 ug. Urine output will be maintained to be greater than 0.5 ml/kg/hour.

At the end of surgery, the nondependent will be re-expanded and TLV will be resumed as before surgery, sevoflurane will be discontinued, the residual neuromuscular block will be antagonized, and the patient will be extubated. Postoperative analgesia will be accomplished with the use of continuous epidural/paravertebral infusion of bupivacaine 0.125% and fentanyl 2 µg/mL.

Statistical Analysis:

Data will be tested for normality using the Kolmogorov-Smirnov test. Fisher exact test will be used for categorical data. Repeated two-way ANOVA and paired t-test will be used to study the changes in the primary and secondary endpoints during each intervention. The Wilcoxon 2 rank sum test will be used for the non-parametric values. We will avoid the carryover effect (persistence of the effect of the first intervention on the operative conditions into the second period) through the comparison of the effects of period (time effect) and the order of treatment using independent t-tests. Data will be expressed as mean ± SD, number (%), or median [range]. A value of P < 0.05 will be considered to be statistically significant.

Conditions
Lung Diseases
Being tested
The PCV-VCV group, The VCV-PCV group
Keywords
Thoracic surgery, one lung ventilation, pressure-controlled ventilation, volume-controlled ventilation, right ventricular function
Medical subject headings
Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The PCV-VCV groupOther

    During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.

  • The VCV-PCV groupOther

    During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.

Study groups in NCT01763879
Study groupRoleWhat they receive
The PCV-VCV groupActive comparatorThe dependent lung will be ventilated with pressure controlled (PCV) followed by the volume-controlled ventilation (VCV)
Receives: Other: The PCV-VCV group
The VCV-PCV groupActive comparatorThe dependent lung will be ventilated with volume-controlled ventilation (VCV) followed by the pressure controlled (PCV)
Receives: Other: The VCV-PCV group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Right ventricular function

    Peak systolic and diastolic tricuspid annular velocity (TAV)

    Measured: Change from baseline at 30 min after the initiation of the intervention

Secondary outcomes (4)
  1. Blood pressure

    Blood pressure

    Measured: Change from baseline at 30 min after the initiation of the intervention

  2. Pa/FiO2 ratio

    the ratio between arterial oxygen tension (PaO2)and inspired fraction of oxygen (FiO2)

    Measured: Change from baseline at 30 min after the initiation of the intervention

  3. Airway pressures

    Peak and plateau airway pressures

    Measured: Change from baseline at 30 min after the initiation of the intervention

  4. Right ventricular volumes

    right ventricular end diastolic and systolic volumes

    Measured: Change from baseline at 30 min after the initiation of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionJan 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763879
Sponsor's protocol ID
2012081
Other IDs
2012081
Status last verified
Jul 2013
First submitted
30 Dec 2012
Last updated
25 Jul 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing The PCV-VCV group and The VCV-PCV group in people with Lung Diseases, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Right ventricular function (time frame: Change from baseline at 30 min after the initiation of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.

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