FastingNCT03273517
Caregivers and Resident Doctors' Perceptions of Preoperative Fasting in Children
An observational study of Fasting, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Elective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2016to 1 Nov 2017
- 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 Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Débora de Oliveira Cumino contact
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa of São Paulo Medical School
São Paulo, São Paulo
Débora de Oliveira Cumino, dcumino@gmail.com
Carolina Lima Moura
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Fasting
- Being tested
- Elective surgery
- Keywords
- Glycemia, Preoperative fasting, Pediatric patients, Anesthesia, Knowledge of the resident
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective surgeryProcedure or surgery
Elective surgery in children aged 0-15 years ASA I and II
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia
After the anesthetic induction, the patients will be subject to the measurement of blood glucose by Dextro.
Measured: 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
The questionnaires will be applied to the guardians of the children who have undergone imaging examination and elective surgery
Measured: 1 hour after post-anesthetic
Secondary outcomes (1)
Knowledge of the resident doctors
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Aug 2016
- Primary completion1 Sep 2017
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for FastingStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lígia Andrade da Silva Telles mathias, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273517
- Sponsor's protocol ID
- 58080016.8.0000.5472
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buller Y, Sims C. Prolonged fasting of children before anaesthesia is common in private practice. Anaesth Intensive Care. 2016 Jan;44(1):107-10. doi: 10.1177/0310057X1604400116.
PubMed 26673596Cantellow S, Lightfoot J, Bould H, Beringer R. Parents' understanding of and compliance with fasting instruction for pediatric day case surgery. Paediatr Anaesth. 2012 Sep;22(9):897-900. doi: 10.1111/j.1460-9592.2012.03903.x. Epub 2012 Jun 25.
PubMed 22731386Cook-Sather SD, Litman RS. Modern fasting guidelines in children. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):471-81. doi: 10.1016/j.bpa.2006.02.003.
PubMed 17080697Flick RP, Schears GJ, Warner MA. Aspiration in pediatric anesthesia: is there a higher incidence compared with adults? Curr Opin Anaesthesiol. 2002 Jun;15(3):323-7. doi: 10.1097/00001503-200206000-00008.
PubMed 17019220Green CR, Pandit SK, Schork MA. Preoperative fasting time: is the traditional policy changing? Results of a national survey. Anesth Analg. 1996 Jul;83(1):123-8. doi: 10.1097/00000539-199607000-00022.
PubMed 8659722Kushnir J, Djerassi R, Sofer T, Kushnir T. Threat perception, anxiety and noncompliance with preoperative fasting instructions among mothers of children attending elective same day surgery. J Pediatr Surg. 2015 May;50(5):869-74. doi: 10.1016/j.jpedsurg.2014.08.018. Epub 2014 Oct 1.
PubMed 25783336MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.
PubMed 20993766Moro ET. [Prevention of pulmonary gastric contents aspiration.]. Rev Bras Anestesiol. 2004 Apr;54(2):261-75. doi: 10.1590/s0034-70942004000200014. Portuguese.
PubMed 19471734Ramirez-Mora J, Moyao-Garcia D, Nava-Ocampo AA. Attitudes of Mexican anesthesiologists to indicate preoperative fasting periods: A cross-sectional survey. BMC Anesthesiol. 2002 May 17;2(1):3. doi: 10.1186/1471-2253-2-3.
PubMed 12019024Schreiner MS, Triebwasser A, Keon TP. Ingestion of liquids compared with preoperative fasting in pediatric outpatients. Anesthesiology. 1990 Apr;72(4):593-7. doi: 10.1097/00000542-199004000-00002.
PubMed 2321772Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Warner MA. Is pulmonary aspiration still an important problem in anesthesia? Curr Opin Anaesthesiol. 2000 Apr;13(2):215-8. doi: 10.1097/00001503-200004000-00023.
PubMed 17016306American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
PubMed 21307770
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregivers and Resident Doctors' Perceptions of Preoperative Fasting in Children
- ClinicalTrials.gov ID
- NCT03273517
- Acronym / sponsor ID
- 58080016.8.0000.5472
- Conditions
- Fasting
- Keywords
- Glycemia, Preoperative fasting, Pediatric patients, Anesthesia, Knowledge of the resident
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 6 Sep 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective surgeryElective surgery in children aged 0-15 years ASA I and II | Procedure or surgery | – |
Primary outcome
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.
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 secondary outcome
Knowledge of the resident doctors
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Results publication: PubMed 26673596Buller Y, Sims C. Prolonged fasting of children before anaesthesia is common in private practice. Anaesth Intensive Care. 2016 Jan;44(1):107-10. doi: 10.1177/0310057X1604400116.
- Results publication: PubMed 22731386Cantellow S, Lightfoot J, Bould H, Beringer R. Parents' understanding of and compliance with fasting instruction for pediatric day case surgery. Paediatr Anaesth. 2012 Sep;22(9):897-900. doi: 10.1111/j.1460-9592.2012.03903.x. Epub 2012 Jun 25.
- Results publication: PubMed 17080697Cook-Sather SD, Litman RS. Modern fasting guidelines in children. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):471-81. doi: 10.1016/j.bpa.2006.02.003.
- Results publication: PubMed 17019220Flick RP, Schears GJ, Warner MA. Aspiration in pediatric anesthesia: is there a higher incidence compared with adults? Curr Opin Anaesthesiol. 2002 Jun;15(3):323-7. doi: 10.1097/00001503-200206000-00008.
- Results publication: PubMed 8659722Green CR, Pandit SK, Schork MA. Preoperative fasting time: is the traditional policy changing? Results of a national survey. Anesth Analg. 1996 Jul;83(1):123-8. doi: 10.1097/00000539-199607000-00022.
- Results publication: PubMed 25783336Kushnir J, Djerassi R, Sofer T, Kushnir T. Threat perception, anxiety and noncompliance with preoperative fasting instructions among mothers of children attending elective same day surgery. J Pediatr Surg. 2015 May;50(5):869-74. doi: 10.1016/j.jpedsurg.2014.08.018. Epub 2014 Oct 1.
- Results publication: PubMed 20993766MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.
- Results publication: PubMed 19471734Moro ET. [Prevention of pulmonary gastric contents aspiration.]. Rev Bras Anestesiol. 2004 Apr;54(2):261-75. doi: 10.1590/s0034-70942004000200014. Portuguese.
- Results publication: PubMed 12019024Ramirez-Mora J, Moyao-Garcia D, Nava-Ocampo AA. Attitudes of Mexican anesthesiologists to indicate preoperative fasting periods: A cross-sectional survey. BMC Anesthesiol. 2002 May 17;2(1):3. doi: 10.1186/1471-2253-2-3.
- Results publication: PubMed 2321772Schreiner MS, Triebwasser A, Keon TP. Ingestion of liquids compared with preoperative fasting in pediatric outpatients. Anesthesiology. 1990 Apr;72(4):593-7. doi: 10.1097/00000542-199004000-00002.
- Results publication: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Results publication: PubMed 17016306Warner MA. Is pulmonary aspiration still an important problem in anesthesia? Curr Opin Anaesthesiol. 2000 Apr;13(2):215-8. doi: 10.1097/00001503-200004000-00023.
- 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.
Débora de Oliveira Cumino contact
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 Fasting, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 5 inclusion and 2 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 6 Sep 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 Brazil. 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 Ligia Mathias, Doctor (+ 55 11 99386-0059, rtimao@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemia (time frame: An average of 1 hour after induction of general anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273517, which also lists 13 linked publications.
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 6 Sep 2017.