Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction, With or Without PEEP

April 4, 2016 updated by: Alex de Leon, Örebro University, Sweden

Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction

Continuous positive pressure during anesthetic induction is today not routinely used partly a to the risk of gastric insufflation because of higher ventilatory pressures. However there are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The investigators aim to compare the risk of gastric insufflation regarding mask ventilation technique, with or without positive end expiratory pressure. For measurements a High Resolution Impedance Manometry Catheter is used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anesthetic induction agents cause a number of physiological changes within the respiratory system. Almost every induction agent causes apnoea. There is a reduction of FRC and an increase in airway resistance. Combined with preoxygenation with a high fraction of oxygen there is a significant risk of pulmonary atelectasis. Adding a continuous positive pressure during ventilation of the apnoeic patient improves many of the respiratory effects caused by induction agents. However the added continuous pressure will increase the total inspiratory pressure and a high inspiratory pressure is associated with an increased risk of gastric insufflation during mask ventilation. On the other hand there are data suggesting that continuous positive pressure is beneficial in treatment of GERD-symptoms.

The investigators hypothesis is, if performed correctly, that the continuous positive pressure will not increase the risk of gastric insufflation. In order to investigate this matter 30 healthy human subjects will undergo anesthetic induction, 15 with no PEEP added and 15 with a PEEP of 10 cm H2O during mask ventilation.

Protocol:

  1. Preoxygenation, 100 % oxygen via Face mask for 3 minutes with 0 PEEP or 10 cm H2O PEEP.
  2. Start of Remifentanil Target Controlled Infusion, target concentration 6 ng/ml.
  3. Propofol 2-2.5mg/kg to adequate depth of anesthesia.
  4. 30 seconds after apnea mask ventilation with Dräger ZEUS IE starting with an inspiratory pressure of 3cm H2O that is gradually increased to a maximum of 30 cm H20 or to signs of air insufflation in the esophagus. Group 1 with 0 PEEP and group 2 with 10 cm H2O PEEP.
  5. End of Remifentanil- and Propofol infusion.

Pressures and passage of air or liquid from pharynx to stomach will be continuously registered during the procedure. For measurements a High Resolution Impedance Manometry Catheter with the ability to measure pressures and impedance simultaneously will be used.

The esophagus and the stomach is divided into four functional units for analysis.

  1. The upper esophageal sphincter
  2. The esophageal body (3 cm below upper esophageal sphincter to 3 cm over the lower esophageal sphincter)
  3. The lower esophageal sphincter
  4. The stomach (3 cm below the lower esophageal sphincter)

The different units are detected in pressure plots where the levels of pressure reflects the anatomical units. Manometric values is specified in mmHg. For detection of passage of air and flow of liquid an impedance baseline is set before measurements start. Passage of air is defined as a sudden rise in impedance of 1 kΩ in anterograde direction. Detection of fluid is defined as a 50% decline in impedance. For analysis of data Mano View analysis software is used.

Pressures and impedance will be continuously recorded during the time frame from preoxygenation to maximum inspiratory pressures are reached. Data will be analysed at each level of pressure 3, 5, 10, 15, 20, 25 and 30 cm H2O. Contained data will be statistically compared between groups.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 70185
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female age 18-40 years
  • Signed and informed consent
  • Subject will and is assumed to be able to follow protocol

Exclusion Criteria:

  • Known gastro intestinal/heart/lung/kidney or neurological disease
  • Use of drugs that interfere with esophageal motility
  • Diabetes
  • Pregnancy or breastfeeding
  • BMI >30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mask ventilation with PEEP
15 subjects will undergo anesthetic induction with application of PEEP of 10 cm H2O during mask ventilation.
Procedure: Mask ventilation with PEEP via a face mask device

15 subjects will undergo anesthetic induction with an application of PEEP of 10 cm H2O during mask ventilation via a face mask.

15 subjects will undergo anesthetic induction without PEEP during mask ventilation via a face mask.
No Intervention: Mask ventilation without PEEP
15 subjects will undergo anesthetic induction without PEEP during mask ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of inspiratory pressure for gastric insufflation
Time Frame: One hour
One hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Pressure changes in the esophagus related to ventilation technique.
Time Frame: One hour
One hour

Other Outcome Measures

Outcome Measure
Time Frame
Pressure changes in the stomach after gastric insufflation
Time Frame: One hour
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Investigators

  • Principal Investigator: Alex deLeon, MD, Phd, Region Örebro County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pelles PEEP-studie

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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