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Thoracic DiseasesNCT05033353

Ventilatory Influence on Cerebral Oxygenation During VATS

A study testing Monitoring of regional cerebral oxygenation in people with Thoracic Diseases, run by Tanta 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

During (OLV) in (VATS) ; many physiological factors may increase risk of hypoxemia such as positioning and intrapulmonary shunt thus compromising cerebral blood flow and oxygenation, resulting in postoperative neurocognitive dysfunctions. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Thoracic Diseases
What is being tested?
Monitoring of regional cerebral oxygenation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSaudi Arabia
Study dates
2 Sep 2021to 10 Jan 2022
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients 18-65 years old
  • Patients withASA I and II
  • Patients with body mass index (BMI) 21-29 kg/m2
  • Patients with admitted for elective VATS requiring OLV for about 1-1.5 h

Who cannot join

  • Patients with severe bronchial asthma
  • Patients with chronic obstructive pulmonary disease
  • Patients with severe renal insufficiency
  • Patients with severe liver dysfunction
  • Patients with cerebrovascular disease
  • Patients with coagulopathy, uncontrolled diabetes mellitus
Show all 10Show fewer
  • Patients with uncontrolled hypertension
  • Patients with cardiovascular disease
  • Patients with mental disabilities
  • Patients with hearing impairment were excluded

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Mona Mohamed Mogahed

    Jeddah

Other trials in Saudi Arabia

About this study

Official title: The Ventilatory Influence on Cerebral Oxygenation in Patients Undergoing VATS

During (OLV) in (VATS) ; many physiological factors may increase risk of hypoxemia such as positioning and intrapulmonary shunt thus compromising cerebral blood flow and oxygenation, resulting in postoperative neurocognitive dysfunctions. The authors hypothesized that increasing (EtCO2) is the most convenient and powerful method for the management of cerebral desaturation. Methods: Seventy patients undergoing VATS were enrolled in this randomized controlled trial. Mechanical ventilation was adjusted to maintain an EtCO2 of 33-38 mm Hg in group I and an EtCO2 of 39-45 mm Hg in group II. Regional cerebral oxygenation was monitored using near-infrared spectroscopy (O3TM, Masimo, Irvine, CA) placed on the patient's forehead.

Read the detailed description

All patients were operated on by the same surgical team. Patients with severe bronchial asthma, chronic obstructive pulmonary disease, severe renal insufficiency, severe liver dysfunction, cerebrovascular disease, coagulopathy, uncontrolled diabetes mellitus, uncontrolled hypertension or cardiovascular disease, mental disabilities, hearing impairment were excluded. Patients were seen on the day of surgery in the preoperative area prior to administration of premedication. A 16 or 18-gauge peripheral venous cannula and a 20-gauge radial artery were inserted to all patients preoperatively. Randomization was done by sealed envelope method and the patients were divided into two groups; group I (targeted EtCO2 32-38 mmHg) and group II (targeted EtCO2 39-45 mmHg).

In the operating room, Patients were monitored by 5 lead electrocardiogram, invasive arterial blood pressure (IABP) through the arterial catheter and (Masimo®, Irvine, CA) which provides non-invasive continuous technologies for monitoring and measuring many physiological variables such as arterial oxygen saturation (SpO2), heart rate (HR) and hemoglobin concentration (Hb%) from the (RD Rainbow® SET Pulse Co-Oximeter), end tidal CO2 by capnometer (Nomoline sampling line Masimo ®, CA), noninvasive blood pressure, body temperature, (O3 ®, Masimo, Irvine, CA) attached to the patient to provide continuous monitoring of regional cerebral oxygen saturation (rSO2) of the two hemispheres by a near-infrared spectroscopy sensors connected to regional oximetry system. The sensors were placed bilaterally on patient's forehead after the skin of the forehead had been wiped with an alcohol swab and allowed to dry as recommended by the manufacturer, and (SedLine ®, Masimo, CA) brain function monitoring by Patient State Index (PSI) which is a processed EEG parameter affected by the anesthetic agents.

Before general anesthesia, an epidural catheter was inserted at T5, 6 or T6, 7 interspace and a test dose of 3 ml of 2% lidocaine with epinephrine was given to exclude intrathecal or intravascular positioning of the catheter, for perioperative administration of 4-8 ml/ h of bupivacaine 0.125%. After preoxygenation for 2 minutes, anesthesia was induced in all patients with propofol 1.5-2 mg /kg, fentanyl 3-5 micg/ kg, and rocuronium 0.6-0.8 mg/ kg. A left-sided double-lumen tube (DLT) (39F for males and 37F for females) (Broncho-Cath; Mallinckrodt Medical Ltd, Athlone, Ireland) was used for endotracheal intubation and checked by fibreoptic bronchoscope (Olympus company, Tokyo, Japan) and auscultation. The patient was then positioned in left or right lateral decubitus position according to the surgical side and the DLT was rechecked again. Maintenance anesthesia was provided by sevoflurane to keep a patient state index (Psi) measured by (SedLine, Masimo®, CA) level between 25-50. Additional doses of fentanyl to a total of 7-15 micg/kg and rocuronium boluses were given to control the depth of anesthesia and to maintain stable neuromuscular block.

Initially, all patients were applied with two-lung ventilation using a constant-flow, volume-controlled ventilation mode with a tidal volume 8 mL/kg of the actual body weight, an inspiratory to expiratory (I:E) ratio of 1:2, a respiratory rate of 12 breaths/min, oxygen flow rate of 1.5 L/min, and FiO2 (fraction of inspiratory oxygen) of 1.0 without PEEP. OLV was initiated with skin incision, and the tube lumen of the dependent non ventilated lung was opened to room air. During OLV, tidal volume was reduced to 7 mL/kg, respiratory rate of 12-15 breaths/min, PEEP of 5 cm H2 O, FiO2 of 1.0, oxygen flow rate of 1.5 L/min, I:E 1:2. Then patients were assigned a ventilation strategy designed to achieve an EtCO2 of 32-3 8mm Hg or of 39-45mmHg in group I or II respectively throughout the intraoperative period by (MAQUET FLOW i anesthesia delivery system). This could be achieved by changing the respiratory rate and inspiratory: expiratory (I:E) ratio . rSO2 values obtained and After achieving and maintaining the target EtCO2 for 3 minutes baseline %ΔrSO2 was considerd and recorded every 10 minutes till the end of surgery. Although the data were available to both the anesthetist, there were no specific recommendations made on possible interventions by the study team. Peak inspiratory pressure (PIP) was monitored using a side stream spirometry device (MAQUET FLOW-i). If PIP >30 cmH2O, the volume controlled ventilation mode was changed to a pressure-controlled mode to achieve a targeted VT. Intraoperative fluid replacement by lactated Ringer's solution or hydroxyethyl starch solution was infused at rate of 8-10 ml/kg/h.

rSPO2, PSi, SpO2, mean BP, and HR were recorded before anesthesia, 5 minutes after intubation, 5 minutes after putting the patient in lateral position, after initiating OLV, after achieving and maintaining this target ETCO2 for 3 minutes, and every 10 min till the end of surgery . Hypotension (defined as more than 20% drop in mean ABP from baseline values obtained on admission to the operating room) was treated with ephedrine in 4 mg increments. We used ephedrine rather than phenylephrine as a previous study showed that cerebral oxygen saturation decreases after phenylephrine but remains unaffected after ephedrine in anaesthetized patients.

ABG analysis by (ABL 800, Radiometer, Copenhagen, Denmark. PaO2, PaCO2 , pH, serum lactate, HCO3 concentration, haemoglobin concentration (Hb) ,and sodium and potassium ion concentrations. ABG was performed before anesthesia, after induction of anesthesia when the patient was in supine position, after positioning in the lateral decubitus position during two lung ventilation (TLV), 15 minutes after one lung ventilation (OLV) and every 15 minutes till the end of surgery. All the patients were in lateral position with head down 10º during surgery. If SpO2 decreased below 92% and lasted 30 seconds during OLV, surgery was temporarily interrupted and two-lung ventilation was resumed. At the end of surgery patient turned supine and neuromuscular block was antagonized with sugamadex 2mg/kg. At the time of closure of thoracic cavity, two-lung ventilation was started and both lungs were re-expanded by hand bagging in all patients. Aldrete scores were recorded by post anesthesia care unit (PACU) nurses blinded to group assignment on arrival to the PACU and then every 15 min thereafter until discharge from PACU. Patients were followed up for any complications of lung during their hospital stays. Delirium was assessed using a validated and widely used Confusion Assessment Method (CAM) rating scale, adapted from Inouye et al, immediately on arrival to hospital, then within 18-24 hours after surgery. Diagnosis of delirium requires the presence of both acute onset with fluctuating course and inattention, together with either disorganized thinking or altered level of consciousness. A single trained interviewer, blinded to randomization and proficient and trained in CAM, conducted all the assessments preoperatively when each patient arrived at the hospital and on the next day after surgery.

Being tested
Monitoring of regional cerebral oxygenation
Keywords
OLV
Medical subject headings
Thoracic Diseases

What participants receive

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

  • Monitoring of regional cerebral oxygenationDiagnostic test

    Regional cerebral oxygenation was monitored using near-infrared spectroscopy (O3TM, Masimo, Irvine, CA) placed on the patient's forehead.

Study groups in NCT05033353
Study groupRoleWhat they receive
Group IActive comparatorMechanical ventilation was adjusted to maintain an EtCO2 of 33-38 mm Hg in group I regional cerebral oxygen monitoring
Receives: Diagnostic Test: Monitoring of regional cerebral oxygenation
Group IIActive comparatorMechanical ventilation was adjusted to maintain an EtCO2 of 39-45 mm Hg in group II regional cerebral oxygen monitoring
Receives: Diagnostic Test: Monitoring of regional cerebral oxygenation

What is being measured

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

  1. Effect of changing end tidal CO2 on the regional cerebral oxygen saturation %

    Intraoperative ventilatory parameters will be adjusted to attain two different end tidal CO2 and the effect on the regional cerebral oxygen saturation % detected

    Measured: 5 months

  2. Heart rate

    Intraoperative heart rate (beat per minute) monitoring allover the surgery

    Measured: 5 months

  3. Blood pressure

    Intraoperative blood pressure (mmHg) monitoring allover the surgery

    Measured: 5 months

Secondary outcomes (1)
  1. Postoperative cognitive function

    Postoperative cognitive function and monitored by a trained personnel

    Measured: 5 months

Timeline

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

  1. First posted2 Sep 2021
  2. Study start2 Sep 2021
  3. Primary completion10 Jan 2022
  4. Study completion10 Jan 2022

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 N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033353
Sponsor's protocol ID
Ministry of health
Status last verified
Jan 2022
First submitted
23 Aug 2021
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Monitoring of regional cerebral oxygenation in people with Thoracic Diseases, run by Tanta 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 4 inclusion and 10 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 12 Jan 2022. 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.

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?

Effect of changing end tidal CO2 on the regional cerebral oxygen saturation % (time frame: 5 months). The study lists 3 primary outcomes in all. 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 12 Jan 2022.

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