Inguinal Hernia BilateralNCT06329817
Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position
A study testing Incidence of regurgitation in two different position. in people with Inguinal Hernia Bilateral, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia Bilateral
- What is being tested?
- Incidence of regurgitation in two different position.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Mar 2024to Sep 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-60 years of age
- Must be able to talk
Who cannot join
- patients less than 18 years of age or above 60,
- Pregnant women
- Handicapped individuals
- patients with intestinal obstruction
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
PEMH
Rawalpindi, Punjab Province, 44000
PEMH, +923317055191, rabbiafatimasattar555@gmail.com
About this study
Official title: Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position in a Tertiary Care Hospital
One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia.
- Conditions
- Inguinal Hernia Bilateral
- Being tested
- Incidence of regurgitation in two different position.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence of regurgitation in two different position.Procedure or surgery
Preventing aspiration pneumonia in general anaesthesia in two different position supine v/s semi - Fowler
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Experimental | Not described Receives: Procedure: Incidence of regurgitation in two different position. |
| Semi- fowler position | Experimental | Not described Receives: Procedure: Incidence of regurgitation in two different position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of aspiration pneumonia
To document incidence of regurgitation
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start16 Mar 2024
- Primary completion15 Nov 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia BilateralStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.Talha Arshad, Pak Emirates Military Hospital
- Investigators
- IRB PEMH Rwp, Study director, CPSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329817
- Sponsor's protocol ID
- A/28/ER/532/23
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT06329817
- Acronym / sponsor ID
- A/28/ER/532/23
- Conditions
- Inguinal Hernia Bilateral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 26 Mar 2024 (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.
One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine position | Experimental | Procedure: Incidence of regurgitation in two different position. |
| Semi- fowler position | Experimental | Procedure: Incidence of regurgitation in two different position. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults 18-60 years of age
- Must be able to talk
Key exclusion criteria (4 listed)
- patients less than 18 years of age or above 60,
- Pregnant women
- Handicapped individuals
- patients with intestinal obstruction
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 |
|---|---|---|
| Incidence of regurgitation in two different position.Preventing aspiration pneumonia in general anaesthesia in two different position supine v/s semi - Fowler | Procedure or surgery | Semi- fowler position, Supine position |
Primary outcome
Prevention of aspiration pneumonia
Time frame: 06 months
To document incidence of regurgitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
IRB PEMH Rwp study director
CPSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incidence of regurgitation in two different position. in people with Inguinal Hernia Bilateral, run by Pak Emirates Military Hospital 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 2 inclusion and 4 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 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Talha Arshad, MBBS (+923368734399, talhaarshad1004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of aspiration pneumonia (time frame: 06 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 19 Sep 2024.