Study on prevention of hypercapnia by carbon dioxide monitoring during sedation for endoscopic submucosal dissectio

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0008801

Lead Sponsor: Samsung Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

ASA class I~III adult
ASA I : a normal healthy patient (healthy, non-smoking, no or minimal alcohol use)
ASA II : A patient with mild systemic disease (Current smoker, social alcohol drinker, 30<40, well-controlled HTN/DM, mild lung disease)
ASA III : A patient with severe systemic disease (Poorly controlled DM or HTN, COPD, morbid obesity, active hepatitis, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, history of MI, CVA, TIA, or CAD/stents more than 3 months ago)
- Undergoing endoscopic submucosal dissection with sedation

Exclusion Criteria

Patients under 18 years of age
Patients requiring oxygen therapy
Patients unable to breathe through the nose
Patients with coagulation disorders or those at risk of nasal bleeding
Patients who have experienced or exacerbated Congestive Heart Failure within the past 6 months
Patients with increased intracranial pressure
Patients classified as ASA class IV or higher
Patients with hemodynamically unstable conditions
Patients with a history of pneumothorax
Patients with infections in the oral or nasal cavities
Pregnant or breastfeeding patients
Patients who do not understand or refuse to participate in the study
Patients with a history of severe psychiatric disorders that may influence patient assessment

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hypercapnia with PtCO2 values increasing by more than 20mmHg from baseline

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoxia (SpO2 < 90%) between the two groups;occurrence rates between the two groups for the following: PtCO2 ranging from 50mmHg to less than 60mmHg (moderate hypercapnia) PtCO2 exceeding 60mmHg (severe hypercapnia) Combined occurrence rate of the above two criteria;Duration of severe hypercapnia (PtCO2 exceeding 60mmHg);Average values of oxygen saturation measured during the procedure;interventions to maintain airway (type, frequency);Comparison of post-procedure chest X-rays (normal, presence of atelectasis or aspiration);Occurrence of complications;Satisfaction of the gastroenterologist;Administration of oxygen upon discharge from the recovery room; First oxygen saturation after discontinuation of oxygen in the recovery room;First oxygen saturation and continuation of oxygen administration upon arrival in the ward ;Maintained BIS (Bispectral index) values during the procedure;Association between the degree of sleep apnea predicted by STOP-Bang and the occurrence of hypercapnia