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.
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.
Belgium1 site, 1 recruiting
- 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
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.
- Conditions
- Complication of Ventilation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control, | control normal ventilation | |
| sellick, | ventilation while sellick manoeuvre is applied | |
| low paratracheal esophagus compression | ventilation while low paratracheal esophagus compression is applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted20 Dec 2017
- Study start22 Mar 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Ventilation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ultrasound-guided Left Paratracheal Esophagus Pressure More Effective Than Cricoid Pressure to Prevent Gastric Insufflation During Positive Pressure Ventilation ?
- ClinicalTrials.gov ID
- NCT03378583
- Acronym / sponsor ID
- ULGANESGAU001
- Conditions
- Complication of Ventilation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a new method to prevent gastric insufflation
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control, | – | –control normal ventilation |
| sellick, | – | –ventilation while sellick manoeuvre is applied |
| low paratracheal esophagus compression | – | –ventilation while low paratracheal esophagus compression is applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients undergoing anesthesia under general anesthesia
Key inclusion criteria (1 listed)
- elective surgery under general anesthesia
Key exclusion criteria (1 listed)
- body mass index above 35 meeting criteria for difficult ventilation and /or intubation risk for aspiration or gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gastric volume
Time frame: within 10 min of induction of anesthesia
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
1 secondary outcome
diameter of the esophagus
Time frame: within 10 min of induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.