AzTrials
AzTrials

Lung DiseasePhase 3NCT02191410

Nondependent Lung Ventilation and Fluid Responsiveness

A Phase 3 study testing High Frequency Positive Pressure Ventilation and Continuous Positive Airway Pressure in people with Lung Disease and Undergoing Thoracosocpic Surgery, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%, specificity: 92.3%).1 Many parameters such as tidal… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
High Frequency Positive Pressure Ventilation and Continuous Positive Airway Pressure
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteSaudi Arabia
Study dates
Jan 2019to Jun 2020
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists physical class of II to III
  • Duration of OLV is expected to exceed 1.5 hours

Who cannot join

  • New York Heart Association class > II
  • Right ventricular dysfunction
  • Pulmonary hypertension
  • valvular heart disease
  • intracardiac shunts
  • Any cardiac rhythm other than sinus
Show all 14Show fewer
  • Hypertension
  • Diabetes mellitus
  • Renal dysfunction
  • Hepatic dysfunction
  • Pregnancy
  • Body mass index >35 kg m-2
  • Peripheral arterial occlusive disease
  • preoperative administration of inotropic medications

Trial locations and contacts

1 site in 1 country.

Abdulmohsin A Al Ghamdi, MD contact

+966 50 581 4737

mohsenkfu@hotmail.com

Saudi Arabia1 site
  • King Fahd Hospital of the University

    Khobar, Eastern Province, 31952

    Abdulmohsen A Al Ghamdi, MD, +966 13 8966666 ext. 2021, mohsenkfu@hotmail.com

    Mohamed R El Tahan, MD

Other trials in Saudi Arabia

About this study

Official title: Comparative Study of the Non-dependent Continuous Positive Airway Pressure and High-frequency Positive-pressure Ventilation on Fluid Responsiveness During One-lung Ventilation for Thoracoscopic Surgery

The stroke volume variation (SVV), measured using the Vigileo-FloTrac system (Edwards Lifescience, Irvine, CA), has been shown to able to predict fluid responsiveness during one-lung ventilation (OLV) in patients undergoing pulmonary lobectomy (sensitivity: 82.4%, specificity: 92.3%).1 Many parameters such as tidal volume (TV),1-2 positive end-expiratory pressure (PEEP),3 respiratory rate (RR), 4 chest and lung compliance,5 heart rate and rhythm, and ventricular function and afterload,6-7 all have been documented to have effects on the SVV.

SVV is calculated as the variation of beat-to-beat SV from the mean value during the most recent 20 seconds of data: SVV = (SVmax - SVmin)/SVmean, where SVmax, SVmin, and SVmean are, respectively, the maximum, minimum, and mean SV determined by the system.

Read more

SVV may not be sufficiently sensitive to predict fluid responsiveness in patients with right ventricular (RV) dysfunction due to concomitant increases in RV afterload, that lead to a decrease in preload variation and subsequent inaccuracy in SVV measurements.8

OLV may increase airway pressure, resulting in increases in the RV afterload, end-diastolic volume, and stroke work index, thus impeding RV function.9-11The increases in the right ventricular afterload may exaggerate the cyclic variation in stroke volume.12

In the authors' previous study,9 they found that the high-frequency positive-pressure ventilation (HFPPV) was superior to continuous positive-airway pressure (CPAP) for OLV, resulting in significantly higher RV ejection fraction, lower RV afterload and higher arterial oxygenation, whereas the former limiting the adequate operative field visualization during video-assisted thoracoscopic surgery (VATS).13

The effects of the nondependent lung ventilation with HFPPV and CPAP on the SVV and fluid responsiveness during OLV has not yet been studied.

Read the detailed description

In all patients, standard monitors, and state and response entropy (SE and RE, respectively) based-depth of anesthesia will be applied. Normothermia will be maintained by using forced-air warming blankets. Anesthetic technique will be standardized in all studied patients. Anesthesiologists who give the anesthetic will be not involved in the collection of outcome data. General anesthesia will be induced with propofol (2-3 mg kg-1) and fentanyl (2-3 µg kg-1) to achieve a SE value less than 50 and the difference between RE and SE less than 10.

Cisatracurium (0.2mg kg-1) will be administered to facilitate the placement of a left-sided double-lumen tube, and the correct position of its tip will be confirmed with a fiberoptic bronchoscope.

Anesthesia will be maintained with 0.7 to 1.5 minimum alveolar concentration of sevoflurane and 0.5 µg kg-1 increments of fentanyl to maintain the SE values less than 50 and the difference between RE and SE less than 10. Suppression of the second twitch in train-of-four stimulation of the ulnar nerve will be maintained with 0.03mg kg-1 increments of cisatracurium.

The radial artery will be catheterized. Cardiac index (CI) and SVV will be measured by using a Vigileo-FloTrac system (v1.14, Edwards Lifescience, Irvine, CA).

Patients' two lungs (TLV) will be mechanically ventilated with a pressure-controlled ventilation mode, a fraction of inspired oxygen (FiO2) of 0.4 in air, TV of 8 mL kg-1 (predicted body weight (PBW)), inspiratory to expiratory (I: E) ratio of 1:2.5 and PEEP of 5 cm H2O, fresh gas flow (FGF) of 1.5-1.7 L min-1, and RR adjusted to achieve a PaCO2 of 35-45 mm Hg.

During OLV,TV, FiO2, I: E ratio, PEEP, FGF, and RR, will be maintained as during TLV and the lumen of the nondependent lung will be left open to air.

After thoracostomy, patients will be randomly allocated to one of two by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code.

The patient's nondependent lung during OLV will be ventilated with a CPAP of 2 cm H2O or HFPPV as randomized.

All patients will receive lactated Ringer's solution at 2mL kg-1 h-1 during surgery. The capability of SVV to predict fluid responsiveness during CPAP or HFPPV will be assessed at 30 min after randomization.

Hemodynamic control will be standardized according to the authors' protocol. If MAP dropped down to 60 mmHg, 250 mL of plasma protein fraction 5% will be administered, and, if this will not enough, repeated doses of intravenous of ephedrine 5 mg or phenylephrine 100 µg, will be administered to maintain urine output to be equal or greater than 0.5 mL kg-1 hour-1. A hemoglobin concentration of 8 g dL-1 or greater will be compensated with red blood cell concentrates.

An independent investigator blinded to the study groups who will not be involved in the patients' management collected the data.

As in previous studies,14-15 the sample size is determined by considering that an area under the ROC curve ≥ 0.8 is clinically reliable to predict fluid responsiveness. To detect a 0.3 difference from the null hypothesis of 0.5, 28 patients will be required in each group with a type-I error of 0.05 and a power of 80% under the ROC curve, assuming equal number of responders and non-responders. To compensate for a dropout rate of 10%, 31 patients will be included in each group.

Normal distributions of data will be assessed using Kolmogorov-Smirnov test. Student's paired t-test or the Wilcoxon signed-rank test will be used to compare hemodynamic variables obtained at the 2 time points (T0, T1) before and after volume expansion. Hemodynamic variables between responders and non-responders within the group at each time point will be compared using Student independent t-test or Mann-Whitney U-test where appropriate. The x2 test will be used when indicated. The Pearson rank method tests linear correlations between SVV before volume loading (T0) and absolute changes in SVV (∆SVV) and percentage change in SVI (∆SVI) after volume. The responders are defined as those patients who demonstrates a ≥ 15% increase in CI after volume expansion between T0 and T1.16 A ROC curve for each variable will be generated and an area under the ROC curve will be calculated. Using this analysis, the optimal threshold value, sensitivity and specificity of SVV during each study intervention could be determined. The ROC curves will be compared using the DeLong test. Data will be expressed as mean ± SD, medians [IQR], or number (%). A value of p< 0.05 is considered to be statistically significant.

Being tested
High Frequency Positive Pressure Ventilation, Continuous Positive Airway Pressure
Keywords
Video-assisted thoracoscopic surgery, one-lung ventilation, continuous positive-airway ventilation, high-frequency positive-pressure ventilation, stroke volume variation, fluid responsiveness
Medical subject headings
Lung Diseases

What participants receive

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

  • High Frequency Positive Pressure VentilationProcedure or surgery

    TV 2 mL kg-1 PBW, I:E ratio > 0.3, RR 60 breaths min-1 and a FGF of < 2 L min-1, using a second identical ventilator with low compliant internal circuit

  • Continuous Positive Airway PressureProcedure or surgery

    CPAP of 2 cm H2O

Study groups in NCT02191410
Study groupRoleWhat they receive
High Frequency Positive Pressure VentilationActive comparatorNot described
Receives: Procedure: High Frequency Positive Pressure Ventilation
Continuous Positive Airway PressurePlacebo comparatorNot described
Receives: Procedure: Continuous Positive Airway Pressure

What is being measured

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

  1. Fluid responsiveness

    To explore the ability of SVV to predict fluid responsiveness with ROC plots

    Measured: 5 min after volume loading

Secondary outcomes (7)
  1. Heart rate

    Measured: 5 min before volume loading, 5 min after volume loading

  2. Stroke volume variation

    Measured: 5 min before volume loading, 5 min after volume loading

  3. Mean blood pressure

    Measured: 5 min before volume loading, 5 min after volume loading

  4. Cardiac index

    Measured: 5 min before volume loading, 5 min after volume loading

  5. Stroke Volume Index

    Measured: 5 min before volume loading, 5 min after volume loading

  6. Airway pressures

    Measured: 5 min before volume loading, 5 min after volume loading

  7. Lung Compliance

    Measured: 5 min before volume loading, 5 min after volume loading

Timeline

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

  1. First posted16 Jul 2014 (estimated)
  2. Study startJan 2019 (estimated)
  3. Primary completionApr 2020 (estimated)
  4. Study completionJun 2020 (estimated)

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02191410
Sponsor's protocol ID
N2014045
Status last verified
May 2018
First submitted
12 Jul 2014
Last updated
24 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High Frequency Positive Pressure Ventilation and Continuous Positive Airway Pressure in people with Lung Disease and Undergoing Thoracosocpic Surgery, 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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 May 2018. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Mohamed R El Tahan, MD (+966 13 865 1193, mohamedrefaateltahan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid responsiveness (time frame: 5 min after volume loading). 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 24 May 2018.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in