Pneumonia, AspirationNCT06705894
Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care
An observational study of Pneumonia, Aspiration, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Aspiration
- How many people
- 10,313 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 28 Feb 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.
Who may be able to join
- Age ≥18 years old;
- Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;
Who cannot join
- Patients with respiratory system symptoms or history before surgery;
- Patients in need of a tracheal intubation;
- Refuse follow-up;
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shangdong, 266000
About this study
Official title: Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care: A Prospective Cohort Study
The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.
Read the detailed description
Gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.With the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.The painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.However, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.
- Conditions
- Pneumonia, Aspiration
- Keywords
- Gastrointestinal endoscopy, Respiratory complications, Sedation
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M group | Gratrointestinal endoscopy is undergone with moderate sedation. | |
| D/G group | Gratrointestinal endoscopy is undergone without deep sedation/general anesthsia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cough
The investigator needs to use NRS scores to evaluate the severity of the cough, if patients develop a new cough after surgery.The score from 0 (no) to 10 (extremely serious).Duration and treatment are also required to be recorded.
Measured: 24 hours after surgery
Postoperative fever
The investigator needs to record the patient's maximum body temperature. Duration and treatment are also required to be recorded.
Measured: 24 hours after surgery
Short of breath
The investigator needs to use mMRC questionnaire to evaluate the severity of SOB.Duration and treatment are also required to be recorded.
Measured: 24 hours after surgery
Secondary outcomes (1)
Adverse events during surgery
Adverse events such as coughing, reflux aspiration, laryngeal spasm, and hypotension need to be recorded.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, AspirationStudies 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
- 10,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jixiangyu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705894
- Sponsor's protocol ID
- QYFYEC2024-218
- Status last verified
- Apr 2025
- First submitted
- 23 Nov 2024
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06705894
- Acronym / sponsor ID
- QYFYEC2024-218
- Conditions
- Pneumonia, Aspiration
- Keywords
- Gastrointestinal endoscopy, Respiratory complications, Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,313 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 26 Nov 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.
The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.
Detailed description
Gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.With the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.The painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.However, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M group | – | –Gratrointestinal endoscopy is undergone with moderate sedation. |
| D/G group | – | –Gratrointestinal endoscopy is undergone without deep sedation/general anesthsia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.
Key inclusion criteria (2 listed)
- Age ≥18 years old;
- Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;
Key exclusion criteria (3 listed)
- Patients with respiratory system symptoms or history before surgery;
- Patients in need of a tracheal intubation;
- Refuse follow-up;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative cough
Time frame: 24 hours after surgery
The investigator needs to use NRS scores to evaluate the severity of the cough, if patients develop a new cough after surgery.The score from 0 (no) to 10 (extremely serious).Duration and treatment are also required to be recorded.
Postoperative fever
Time frame: 24 hours after surgery
The investigator needs to record the patient's maximum body temperature. Duration and treatment are also required to be recorded.
Short of breath
Time frame: 24 hours after surgery
The investigator needs to use mMRC questionnaire to evaluate the severity of SOB.Duration and treatment are also required to be recorded.
1 secondary outcome
Adverse events during surgery
Time frame: During surgery
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 2 Jan 2026.
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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?
An observational study of Pneumonia, Aspiration, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 3 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 2 Jan 2026. 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 China. 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?
Postoperative cough (time frame: 24 hours after surgery). The study lists 3 primary outcomes in all. 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 2 Jan 2026.