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Completed

NCT Number: NCT06705894

Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care

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.

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Key information

Conditions

Pneumonia, Aspiration Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shangdong, 266000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old;
  • Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;

Exclusion criteria

  • Patients with respiratory system symptoms or history before surgery;
  • Patients in need of a tracheal intubation;
  • Refuse follow-up;

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Adverse events during surgery

    Time frame: During surgery

    Adverse events such as coughing, reflux aspiration, laryngeal spasm, and hypotension need to be recorded.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Risk of Respiratory Complications Following Gastrointestinal Endoscopy Under Monitored Anesthesia Care: A Prospective Cohort Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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