Gastro-Intestinal DisordersNCT03920046
Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
An observational study of Gastro-Intestinal Disorders, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Gastro-Intestinal Disorders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 518 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 1 Mar 2021
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Esophagogastroduodenoscopy patients are included in the study
Who may be able to join
- ASA ( American Society of Anesthesiologists) I- ASA II patients
- Aged 1- 18 Year old patients
Who cannot join
- Smoker patients
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.
Read the detailed description
When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.
- Conditions
- Gastro-Intestinal Disorders
- Being tested
- Control Group
- Keywords
- esophagogastroduodenoscopy, laryngospasm, passive smoking, sedation
- Medical subject headings
- Laryngismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupBehavioural
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking.
| Study group | Role | What they receive |
|---|---|---|
| Effects of passive smoking on children | The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngospasm ratio
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.
Measured: an average of 2 hours
Secondary outcomes (1)
hypoxia ratio (oxygen saturation < % 90)
The prevalence of hypoxia (oxygen saturation < % 90) in sedation applied to endoscopic intervention whose parents smoking.
Measured: an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start2 Jan 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastro-Intestinal DisordersStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 518 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Seçkin Pehlivan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920046
- Sponsor's protocol ID
- 2018/641
- Status last verified
- Mar 2021
- First submitted
- 8 Apr 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De- identified individual participant data for all primary and secondary outcome measures will be available.
Publications
Chung HK, Lightdale JR. Sedation and Monitoring in the Pediatric Patient during Gastrointestinal Endoscopy. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):507-25. doi: 10.1016/j.giec.2016.02.004.
PubMed 27372774Rodrigo C. The effects of cigarette smoking on anesthesia. Anesth Prog. 2000 Winter;47(4):143-50.
PubMed 11432181Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.
PubMed 17767636Pehlivan SS, Gergin OO, Bayram A, Altay D, Arslan D, Bicer C, Aksu R. The effect of passive smoking on the laryngospasm rate in children sedated during the esophagogastroduodenoscopy. Saudi Med J. 2022 Mar;43(3):275-282. doi: 10.15537/smj.2022.43.3.20210784.
PubMed 35256495
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT03920046
- Acronym / sponsor ID
- 2018/641
- Conditions
- Gastro-Intestinal Disorders
- Keywords
- esophagogastroduodenoscopy, laryngospasm, passive smoking, sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 Apr 2019 (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.
To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.
Detailed description
When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effects of passive smoking on children | – | Behavioral: Control GroupThe prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Esophagogastroduodenoscopy patients are included in the study
Key inclusion criteria (2 listed)
- ASA ( American Society of Anesthesiologists) I- ASA II patients
- Aged 1- 18 Year old patients
Key exclusion criteria (1 listed)
- Smoker patients
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 |
|---|---|---|
| Control GroupThe prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking. | Behavioural | Effects of passive smoking on children |
Primary outcome
laryngospasm ratio
Time frame: an average of 2 hours
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.
1 secondary outcome
hypoxia ratio (oxygen saturation < % 90)
Time frame: an average of 2 hours
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 16 Mar 2021.
- Results publication: PubMed 27372774Chung HK, Lightdale JR. Sedation and Monitoring in the Pediatric Patient during Gastrointestinal Endoscopy. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):507-25. doi: 10.1016/j.giec.2016.02.004.
- Results publication: PubMed 11432181Rodrigo C. The effects of cigarette smoking on anesthesia. Anesth Prog. 2000 Winter;47(4):143-50.
- Results publication: PubMed 17767636Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.
- Derived from this study: PubMed 35256495Pehlivan SS, Gergin OO, Bayram A, Altay D, Arslan D, Bicer C, Aksu R. The effect of passive smoking on the laryngospasm rate in children sedated during the esophagogastroduodenoscopy. Saudi Med J. 2022 Mar;43(3):275-282. doi: 10.15537/smj.2022.43.3.20210784.
- Individual participant dataSharing planned: Yes. De- identified individual participant data for all primary and secondary outcome measures will be available.
Related trials for Gastro-Intestinal Disorders
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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?
An observational study of Gastro-Intestinal Disorders, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 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 16 Mar 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 Turkey (Türkiye). 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?
laryngospasm ratio (time frame: an average of 2 hours). 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 NCT03920046, which also lists 4 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 16 Mar 2021.