Caregivers and Resident Doctors' Perceptions of Preoperative Fasting in Children

September 2, 2017 updated by: Lígia Andrade da Silva Telles mathias, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Historically, adults and children who undergo elective surgery remain fasting in the preoperative period, for the purposes of avoiding bronchial aspiration of the gastric contents during general anesthesia. The determination of preoperative fasting has taken on importance only in 1946, when Mendelson established a relationship between pulmonary aspiration during labor and general anesthesia. Stemming from other studies, such concept has been expanded to elective surgery and 25 ml were set as the maximum threshold of the gastric content to thus reduce the hazards of aspiration pneumonia.

The fasting time prescribed is still the subject of several investigations. For decades it has been established that patients should not feed on solids or ingest liquids over a period of 8 to 12 hours prior to surgery.

The guidelines are well set in connection with the rules of fasting, with aims at making the instructions constant throughout different services worldwide. In 2011, the American and the European guidelines became more permissive and determined as safe the 2 hours for liquids devoid of residue, 4 hours for breast milk, 6 hours for infant formula and non-human milk, 6 hours for light meals, and 8 hours for full meals. In accordance with the American guideline, liquids devoid of residue are: water, fruit juice with no pulp, carbohydrate-based beverages, tea with no residue, and black coffee, but those examples are not extensive. Gelatin is solid prior to intake, but it is found in a liquid state inside the stomach and, therefore, it is regarded as a liquid devoid of residue. Yet, in spite of the non-human milk's being a liquid material, it features a gastric emptying time which is similar to that of the non-fat solids. A light meal is characterized by toast and liquids devoid of residue, whilst a full meal includes food that is fried or which contains a high level of fat.

Currently, many directives (American Society of Anaesthesiologists - ASA; Norwegian National Consensus Guideline - NNCG; Association of Anaesthetists of Great Britain and Ireland - AAGBI) recommend liquids devoid of residue until two hours prior to the anesthetic induction for elective surgery in healthy children. The particular benefit of the oral intake of fluids includes a lower incidence of deleterious effects, such as thirst, irritation, crying, hypoglycemia, and dehydration. The preservation of the intravascular volume improves the hemodynamic conditions during the induction of inhalation anesthesia and facilitates the vascular access.

Even though the old instruction of "nothing by mouth after midnight" is in a process of being replaced by shorter periods of fasting, both surgeons and anesthesiologists still deem the traditional fast indispensable and have trouble with implementing the new norms, either by uncertainty before the possibility of the catastrophic consequences of pulmonary aspiration, or by lack of update on the subject. That matter generates mistakes in the rendering of information by the health professionals. Combined with the unawareness of the guardians in respect of the risk of bronchial aspiration and the anxiety in relation to the fasting, there is a result of difficulty in abidance by the proper preoperative fasting.

The minority of the guardians understands the real importance of the preoperative fasting and, many times, food regarded as "harmless" is offered during the period of fasting. Likewise, the guardians provide improper information in order to maintain the surgical procedure, with no regard for the correct observance of the fasting. That way, countless pediatric elective surgeries are canceled, deriving in psychological, social, and economic implications. The correction of these flaws will allow for the anesthetic procedure to take place in a more secure manner, with the proper observance of the fasting period and with the least possible trauma to the child.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cross-sectional, observational study in which questionnaires will be applied to the guardians during the immediate post-surgical period in the anesthetic recovery room by residents of the third year of anesthesiology.

Moreover, the knowledge of the physicians of the surgical specialties of the aforementioned institution pursuant to preoperative fasting is to be assessed, whilst a questionnaire will be applied after the meetings of the respective departments.

After explication of the study, the Informed Consent Form will be handed in the pre-anesthetic consultation, and the questionnaires will be applied in the post-anesthetic recovery room to the guardians of the children who have undergone imaging examination and elective surgery. After the anesthetic induction, the patients will be subject to the measurement of blood glucose by Dextro. The resident doctors will be evaluated by means of another questionnaire, which is to be applied after the weekly clinical meeting of each specialty.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Contact

  • Name: Ligia Mathias, Doctor
  • Phone Number: + 55 11 99386-0059
  • Email: rtimao@uol.com.br

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Recruiting
        • Santa Casa of Sao Paulo Medical School
        • Contact:
        • Sub-Investigator:
          • Carolina Lima Moura
        • Sub-Investigator:
          • Fernanda Bourroul Villela Pedras
        • Sub-Investigator:
          • Maíra Fernandes Gonçalves

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

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Children below 15 years of age, subject to ophthalmological, otorhinolaryngological, orthopedic, and pediatric elective surgery and imaging examinations, with ASA I and II physical condition, and their guardians, over a period of three months.
  • Resident doctors of the specialties of general and pediatric surgery, ophthalmology, otorhinolaryngology, anesthesia, general orthopedics, a pediatric orthopedics.

Description

Inclusion Criteria:

  • Literate parents or guardians;
  • Children with indication for general anesthesia;
  • Children between 0 and 15 years of age;
  • Children with ASA I and II physical condition.
  • Resident doctors of the specialties of general and pediatric surgery, ophthalmology, otorhinolaryngology, anesthesia, general orthopedics, a pediatric orthopedics.

Exclusion Criteria:

  • Children subject to anesthetic induction by means of the rapid sequence technique.
  • Children with alterations in the gastric emptying (diabetes, obesity, neonatal hypoxic encephalopathy, usage of gastrostomy and of nasogastric and nasoenteric probes).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemia
Time Frame: An average of 1 hour after induction of general anesthesia
After the anesthetic induction, the patients will be subject to the measurement of blood glucose by Dextro.
An average of 1 hour after induction of general anesthesia
The understanding and the perception of the guardians in relation to the importance of fasting in pediatric patients
Time Frame: 1 hour after post-anesthetic
The questionnaires will be applied to the guardians of the children who have undergone imaging examination and elective surgery
1 hour after post-anesthetic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of the resident doctors
Time Frame: Through study completion, an average of 1 year
The knowledge of the physicians of the surgical specialties of the aforementioned institution pursuant to preoperative fasting is to be assessed, whilst a questionnaire will be applied
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

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 (Actual)

August 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

September 2, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 58080016.8.0000.5472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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