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Complication of Ventilation TherapyNCT03378583

Prevention of Gastric Insufflation During Positive Pressure Ventilation ?

An observational study of Complication of Ventilation Therapy, run by University of Liege at 1 site in Belgium.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Evaluation of a new method to prevent gastric insufflation Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Complication of Ventilation Therapy
How many people
90 participants
Where
1 siteBelgium
Study dates
22 Mar 2017to Feb 2018
Phase
Observational
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
  • Adult, Older adult

Study population: patients undergoing anesthesia under general anesthesia

Who may be able to join

  • elective surgery under general anesthesia

Who cannot join

  • body mass index above 35 meeting criteria for difficult ventilation and /or intubation risk for aspiration or gastric surgery

Trial locations and contacts

1 site in 1 country.

Jean François Brichant, MD, PhD contact

0032 43667655

jfbrichant@chu.ulg.ac.be

Philippe Gautier, MD contact

0032 477 360031

p.gautier@skynet.be

Belgium1 site, 1 recruiting
  • CHU de Liege

    Liège, Liege, 4000

    Jean Francois Brichant, MD, PhD, 0032 43667180, jfbrichant@ulg.chu.ac.be

    Philippe Gautier, MD, 0032477360031, p.gautier@skynet.be

    Recruiting

Other trials in Belgium

About this study

Official title: Is Ultrasound-guided Left Paratracheal Esophagus Pressure More Effective Than Cricoid Pressure to Prevent Gastric Insufflation During Positive Pressure Ventilation ?

Evaluation of a new method to prevent gastric insufflation

Read the detailed description

After Ethics Committee approval of the University of Liège and written informed consent, 90 ASA 1-2 patients aged 18-65 years and scheduled for elective surgery under general anesthesia will be enrolled in the study. Exclusion criteria are body mass index (BMI) above 35; meeting criteria for difficult ventilation and/or intubation, such as oropharyngeal pathology or facial or cervical abnormalities; and risk for aspiration or previous gastric surgery. Patients will be randomly allocated 1:1:1 (30 patients/group) by the method of sealed envelopes to left low paratracheal esophageal compression (LPEC), cricoid pressure (CP), or no pressure intervention (Control). Neck circumference will be measured. No premedication will be given prior to the study interventions.

Part 1: Ultrasound assessment of the esophagus at the left lower paratracheal level

Esophageal examinations will be conducted by ultrasound with the patient supine and head in neutral position. Feasibility of imaging and compressing the esophagus approximately 2-3 cm above the clavicle was assessed as follows:

A linear ultrasound probe (Applio XG iStyle Toshiba with a 14-7 Mhz) was positioned in a transverse (axial) orientation over the left paratracheal area (Figure 1(A)), 2-3 cm above the clavicle. The position of the esophagus in relation to the trachea (left, right or not seen) will be recorded. Once the esophagus will be identified, the antero-posterior diameter (mm) will be measured and compared before and after applying an estimated pressure of 30 N (as described below) or until a bony contact will be established with the transducer. Esophageal compression will be re-assessed using a paramedian sagittal plane between the trachea and the sternocleidomastoid muscle with the esophagus in sagittal plane. The antero-posterior diameter (mm) measurements will be repeated before and after applying pressure with the transducer. Three consecutive measures for each probe position were recorded.

Part 2: Assessment of the presence of gastric (antral) air With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. 9 The cross-sectional area of the antrum was measured at the level where both the aorta and upper mesenteric artery were visible. Three consecutive measures were taken (a) before the induction of anesthesia and (b) after 3 min of PPV via face mask. The presence of gastric air insufflation is defined as an increase in cross-sectional area and/or presence of artifacts in the antrum (comet tail, posterior acoustic shadow). 9 These assessments will be performed by a sonographer, blinded to group allocation by a surgical drape placed between the thorax and the abdomen.

Pressure maneuvers Two anesthesiology residents, not informed of the study outcome measurements, will be trained to apply sustained pressure of 30 ± 5 N using an electronic dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah), until 10 consecutive maneuvers will be measured successfully (30 ± 5 N). For cricoid pressure, the cartilage will be compressed with the thumb and index fingers toward the vertebral bodies (Sellick). For LPEC, the thumb will be placed over the base of the neck on the left side of the trachea 2-3 cm above the clavicle and medial to the sternocleidomastoid muscle (Figure 1(B)).

ASA monitoring will be applied, and anesthesia will be induced with propofol 2.5 mg/kg administered over 45 sec. Remifentanil will be administered with an infusion pump (2 to 3 μg/kg over 60 sec during induction, followed by continuous infusion of 0.05μg /kg/min). After general anesthesia will be induced, PPV was accomplished with a face-mask in pressure-control mode while maintaining a positive inspiratory pressure of 25 cm H2O, (Zeus ventilator, Dräger, Lübeck, Germany). The ventilator settings will be 100% oxygen, I:E ratio 1:2, 15 breaths/min, no positive end-expiratory pressure. Adequacy of ventilation will be documented by chest raise and capnography. Antral measurements will be taken after 3 min of face-mask ventilation by a sonographer blinded to group assignment. Thereafter, the management of anesthesia care will be continued as per institutional standards.

What participants receive

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

Study groups in NCT03378583
Study groupRoleWhat they receive
control,control normal ventilation
sellick,ventilation while sellick manoeuvre is applied
low paratracheal esophagus compressionventilation while low paratracheal esophagus compression is applied

What is being measured

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

  1. gastric volume

    With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. The cross-sectional area of the antrum will be measured at the level where both the aorta and upper mesenteric artery will be visible

    Measured: within 10 min of induction of anesthesia

Secondary outcomes (1)
  1. diameter of the esophagus

    A linear ultrasound probe (Applio XG iStyle Toshiba with a 14-7 Mhz) will be positioned in a transverse (axial) orientation over the left paratracheal area (Figure 1(A)), 2-3 cm above the clavicle. The position of the esophagus in relation to the trachea (left, right or not seen) will be recorded. When the esophagus will be identified, the antero-posterior diameter (mm) will be measured and compared before and after applying an estimated pressure of 30 N.

    Measured: within 10 min of induction of anesthesia

Timeline

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

  1. First posted20 Dec 2017
  2. Study start22 Mar 2017
  3. Primary completionFeb 2018 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378583
Sponsor's protocol ID
ULGANESGAU001
Status last verified
Dec 2017
First submitted
14 Dec 2017
Last updated
20 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Complication of Ventilation Therapy, run by University of Liege at 1 site in Belgium.

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 1 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 20 Dec 2017. 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 Belgium. 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?

Results are not available in the source record.

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

Contact Jean François Brichant, MD, PhD (0032 43667655, jfbrichant@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gastric volume (time frame: within 10 min of induction of anesthesia). 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 20 Dec 2017.

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