Pulmonary Aspiration of Gastric ContentsNCT05922072
Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
A study testing Nasogastric aspiration for measurement of Residual Gastric Volume and Nasogastric Aspiration for Measurement of Gastric pH in people with Pulmonary Aspiration of Gastric Contents, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents
- What is being tested?
- Nasogastric aspiration for measurement of Residual Gastric Volume and Nasogastric Aspiration for Measurement of Gastric pH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2021to 3 Dec 2021
- Phase
- Interventional
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both male and female patients
- Age between 1 to 12 years
- Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia
Who cannot join
- 1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Paeds Surgery Department Mayo Hospital
Lahore, Punjab Province, 54000
About this study
Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.
Read the detailed description
Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia.
Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Being tested
- Nasogastric aspiration for measurement of Residual Gastric Volume, Nasogastric Aspiration for Measurement of Gastric pH
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric aspiration for measurement of Residual Gastric VolumeProcedure or surgery
The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.
Nasogastric Aspiration for Measurement of Gastric pHProcedure or surgery
The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.
| Study group | Role | What they receive |
|---|---|---|
| Long NPO group | Active comparator | 6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively Receives: Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume; Procedure: Nasogastric Aspiration for Measurement of Gastric pH |
| Short NPO group | Experimental | 6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively Receives: Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume; Procedure: Nasogastric Aspiration for Measurement of Gastric pH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean residual gastric volume
Mean Residual Gastric Volume will be measured in mililiter
Measured: 6 Months
Secondary outcomes (1)
Gastric pH
Gastric pH will be measured by pH Litmus paper
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start3 Jun 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Aspiration of Gastric ContentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total 120 patients will be randomly allocated into two groups using computerized generated numbers (60 in each group). Group A with 6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively. Group B with 6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Numeri, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922072
- Sponsor's protocol ID
- KingEdwarMU
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
- ClinicalTrials.gov ID
- NCT05922072
- Acronym / sponsor ID
- KingEdwarMU
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 28 Jun 2023 (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.
Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.
Detailed description
Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia.
Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total 120 patients will be randomly allocated into two groups using computerized generated numbers (60 in each group). Group A with 6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively. Group B with 6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
| Arm | Type | Receives |
|---|---|---|
| Long NPO group | Active comparator | Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume, Procedure: Nasogastric Aspiration for Measurement of Gastric pH6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively |
| Short NPO group | Experimental | Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume, Procedure: Nasogastric Aspiration for Measurement of Gastric pH6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both male and female patients
- Age between 1 to 12 years
- Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia
Key exclusion criteria (1 listed)
- 1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.
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 |
|---|---|---|
| Nasogastric aspiration for measurement of Residual Gastric VolumeThe patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate. | Procedure or surgery | Long NPO group, Short NPO group |
| Nasogastric Aspiration for Measurement of Gastric pHThe patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate. | Procedure or surgery | Long NPO group, Short NPO group |
Primary outcome
Mean residual gastric volume
Time frame: 6 Months
Mean Residual Gastric Volume will be measured in mililiter
1 secondary outcome
Gastric pH
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastric aspiration for measurement of Residual Gastric Volume and Nasogastric Aspiration for Measurement of Gastric pH in people with Pulmonary Aspiration of Gastric Contents, run by King Edward Medical University at 1 site in Pakistan.
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 3 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 28 Jun 2023. 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 Pakistan. 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?
Mean residual gastric volume (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2023.