Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02906267
Other study ID # Ultrasonic gastric volume
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2016
Last updated July 13, 2017
Start date December 2016
Est. completion date December 2017

Study information

Verified date July 2017
Source University Hospital, Brest
Contact Pierre LAFERE, MD, PhD
Phone 0033298347658
Email pierre.lafere@chu-brest.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)


Description:

Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.


Recruitment information / eligibility

Status Recruiting
Enrollment 123
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA status I and II

Exclusion Criteria:

- Pregnant woman Obese patient (BMI>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diagnostic ultrasonography of gastric volume
Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)

Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric volume before and after positive pressure ventilation 15 minutes
Secondary Ultrasonographic detection of gastric insufflation during ventilation 15 minutes
See also
  Status Clinical Trial Phase
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Completed NCT04500353 - Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial N/A
Completed NCT02805036 - Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit N/A
Completed NCT04306757 - Flow Controlled Ventilation in Cardiac Surgery N/A
Completed NCT03795753 - Determining the Benefits of Improving Communication in BPAP/CPAP Users N/A
Recruiting NCT06430554 - Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability
Completed NCT03244891 - Autonomic Challenges From Mild Hypovolemia and Mechanical Ventilation N/A
Completed NCT03203577 - Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure N/A
Completed NCT03256578 - Monitoring Neonatal Resuscitation Trial N/A
Completed NCT03435913 - Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery N/A