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

Study on prevention of hypercapnia by carbon dioxide monitoring during sedation for endoscopic submucosal dissection: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008801

Enrollment

120

Registered

2023-09-15

Start date

2023-10-10

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : In the case of the control group, the PtCO2 value is masked from the anesthesiologist's view, while in the intervention group, interventions are aimed at maintaining PtCO2 levels within 20mmH

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of hypercapnia with PtCO2 values increasing by more than 20mmHg from baseline	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactSeungwon Lee

Samsung Medical Center

seungwon0209.lee@samsung.com+82-2-3410-0369

Outcome results