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FastingNCT03448991

Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH

An observational study of Fasting and Pediatric ALL, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

According to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. The practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period… Read more about this study

Who is it for?
Ages Up to 17 yearsHealthy volunteers can take part
Conditions the study is for
Fasting, Pediatric ALL
How many people
150 participants
Where
1 siteUnited States
Study dates
24 Aug 2018to 11 Dec 2019
How long will I take part?
1 Day
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 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: The study will include all patients who aged 0-17 years scheduled for EGD procedure at GPU, Boston Children's Hospital, Longwood.

Who may be able to join

  • All patients who aged 0-17 years scheduled for EGD procedure.

Who cannot join

  • Patients who required emergency EGD procedures and patients with active upper GI bleeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston children hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

According to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. The practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. As a result of longer fasting period, patients tend to experience preoperative dehydrated states and intraoperative hypotension. Patients' demographic data will be obtained from charts. Parents will be asked for type, volume of fluid/food intake and NPO time.

This study will be done at BCH's Gastroenterology Procedure Unit (GPU) theaters to measure actual intragastric volume and pH at the beginning esopagogastroduodenoscopy procedures. We hope to demonstrate the relationship between NPO time and actual intragastric volume which provide sufficient data of NPO time to ensure patient's safety.

Read the detailed description

This study is a prospective observational cohort study which will be conducted in 2 parts including preoperative and intraoperative periods.

  • Preoperative period, patients' demographic information will be collected along with NPO history including times, type ,amount of preoperative fluid/ food intake and patients' anxiety score.
  • Intraoperatively, at the beginning of EGD procedure, total volume of intragastric content(ml) and gastric acidity will be measured.

We plan to offer participation to all patients or parents of patients' ages 0-17 years who are scheduled for EGD at GPU, BCH Longwood campus and are fluent in English. A brochure describing our study in English will be given to patients or their families on the day of surgery. If the patient or family agrees to participate in this study, the study will be provided in the GPU theaters.

Keywords
NPO time, Gastric content, Gastric pH
Medical subject headings
Fasting, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Actual intragastric content volume (ml)

    Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured

    Measured: 1 day

Secondary outcomes (7)

  1. Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).

    Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).

    Measured: 1 day

  2. Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).

    Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).

    Measured: 1 day

  3. Incidence of perioperative hypotension

    Hypotension is defined as 20% reduction of normal systolic blood pressure for any age groups

    Measured: 1 day

  4. Incidence of pulmonary aspiration risk.

    Pulmonary aspiration is defined by the regurgitation of gastric contents into the larynx and the respiratory tract and cause a syndrome of progressive dyspnea, hypoxia, bronchial wheeze and patchy collapse, consolidation on chest X-ray or all.

    Measured: 1 day

  5. Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)

    Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)

    Measured: 1 day

  6. Incidence of surgery delay or cancellation due to NPO guideline violation

    Surgery delay is defined when the patient's queue is postponed in order to wait for proper NPO time

    Measured: 1 day

  7. Actual pH of intragastric content

    Actual pH of intragastric content which is suctioned from each pediatric patient is measured

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start24 Aug 2018
  3. Primary completion11 Dec 2019
  4. Study completion11 Dec 2019

Resources

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
150 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448991
Sponsor's protocol ID
IRB-P00027981
Status last verified
Jan 2021
First submitted
20 Feb 2018
Last updated
19 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

    PubMed 28045707

  • Smith 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 21712716

  • Maltby JR, Sutherland AD, Sale JP, Shaffer EA. Preoperative oral fluids: is a five-hour fast justified prior to elective surgery? Anesth Analg. 1986 Nov;65(11):1112-6.

    PubMed 3767008

  • Andersson H, Zaren B, Frykholm P. Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite. Paediatr Anaesth. 2015 Aug;25(8):770-777. doi: 10.1111/pan.12667. Epub 2015 May 4.

    PubMed 25940831

  • Phillips S, Daborn AK, Hatch DJ. Preoperative fasting for paediatric anaesthesia. Br J Anaesth. 1994 Oct;73(4):529-36. doi: 10.1093/bja/73.4.529.

    PubMed 7999497

  • Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sumpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study. Paediatr Anaesth. 2016 Aug;26(8):838-43. doi: 10.1111/pan.12943. Epub 2016 Jun 13.

    PubMed 27291355

  • Song IK, Kim HJ, Lee JH, Kim EH, Kim JT, Kim HS. Ultrasound assessment of gastric volume in children after drinking carbohydrate-containing fluids. Br J Anaesth. 2016 Apr;116(4):513-7. doi: 10.1093/bja/aew031.

    PubMed 26994229

  • Schmitz A, Kellenberger CJ, Liamlahi R, Studhalter M, Weiss M. Gastric emptying after overnight fasting and clear fluid intake: a prospective investigation using serial magnetic resonance imaging in healthy children. Br J Anaesth. 2011 Sep;107(3):425-9. doi: 10.1093/bja/aer167. Epub 2011 Jun 14.

    PubMed 21676893

Questions about this trial

What is this clinical trial studying?

An observational study of Fasting and Pediatric ALL, run by Boston Children's Hospital at 1 site in United States.

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: finished, as of the sponsor's last update on 19 Jan 2021. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Actual intragastric content volume (ml) (time frame: 1 day). 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 NCT03448991, which also lists 8 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 19 Jan 2021.

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