Endtidalcarbondioxide Monitoring

NCT ID: NCT04177927

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-10-01

Brief Summary

Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical Advantage?

Detailed Description

This study will be randomized prospectively and conducted in Sancaktepe Prof.Dr. Dr. İlhan Varank Training and Research Hospital Endoscopy Unit. After the approval from institute ethics committee, and obtaining written informed consent, sixty patients with ASA I-II who underwent lumbar spinal surgery between 18 and 65 years of age were included in the study. Patients with existing heart and lung disease, liver and kidney failure, morbidly obese, using psychiatric drugs, having malignancy, pregnant and lactating patients will not be included in the study. All patients admitted to the endoscopy unit will be monitorized for noninvasive arterial blood and BiS (Bispectral Index) monitorization. Some of the patients will undergo standard monitoring HR (heart rate) and SpO2 (peripheral oxygen saturation). Other patients will be placed in appropriate nasal cannula Capnostream 20p / Coviden for etCO2 (End tidal CO2), RR (Respitarory rate), SpO2 and PR (heart rate) monitorization. Prior to endoscopic intervention, fentanyl 1mcgr/kg iv and propofol 1mg/kg iv will be administered to patients for sedation. During the procedure, the BiS value will be arranged 60-85 and propofol 10-30 mg will be administered intravenously if necessary. If sedation is insufficient, fentanyl 25 mcg iv will be added. After baseline values are recorded mean arterial pressure, BiS values, etCO2, RR, SpO2, PR, iPi (Integrated Pulmonary Index) score values will be recorded at 5 minute intervals after the procedure has started. At the end of the procedure, ODI (Oxygenesaturation Index), A/Hr (hourly apnea) values will be recorded.

Undesirable events like apnea, desaturation will be intervened and duration of it will be recorded. Apnea is described as the breathing stops (ETCO2 = 0mmHg, RR = 0 ) for more than 30 seconds and desaturation is described the fall in SpO2 value below 4% of initial value lasting for at least 4 minutes. When apnea and desaturation are seen, verbal stimulation, jaw lifting maneuver and oxygen flow will be increased. If the apnea and desaturation periods of the patients are prolonged or the SpO2 value falls below 10% of the initial value despite the interventions, the procedure will be terminated and necessary procedures will be performed to ensure airway safety and the study will be terminated.

Patients who have completed the endoscopic intervention will be taken to the recovery unit and the Fast-tracking recovery score will be calculated at 10 minute intervals in the first hour. The time that the fast-tracking score is 14 will be recorded. Patients with two consecutive Fast-tracking recovery score values 14 will be discharged. Patients will be called after 24-48 hours and questioned if they have symptoms such as abdominal distension, fever, nausea and vomiting, dizziness and weakness. The satisfaction score to the patient will be questioned; 1:not satisfied at all, 2: not satisfied, 3: neutral, 4:satisfied, 5: very satisfied.

Conditions

Gastrointestinal Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

endtidalcarbondioxide monitoring group

The patients performed gastrointestinal endoscopy will be monitored with Capnostream 20p / Coviden for etCO2 (End tidal CO2), RR (Respitarory rate), SpO2 and PR (heart rate).

Group Type: EXPERIMENTAL

Capnostream 20p / Coviden

Intervention Type: DEVICE

The special nasal canule is used for detection carbondioxide from breathe of patients

Control Group

Rutine monitorization will be performed to control group of patients.

Group Type: ACTIVE_COMPARATOR

Rutine monitoring

Intervention Type: DEVICE

peripheric Oxygen saturation is monitored.

Interventions

Capnostream 20p / Coviden

The special nasal canule is used for detection carbondioxide from breathe of patients

Intervention Type: DEVICE

Rutine monitoring

peripheric Oxygen saturation is monitored.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ASA I-II
• underwent gastrointestinal endoscopy

Exclusion Criteria

• existing heart and lung disease
• liver and kidney failure
• morbid obese
• using psychiatric drugs
• having malignancy
• pregnant and lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

mesure gul nihan ozden

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurten Bakan, doctor

Role: STUDY_DIRECTOR

Ministry of Health University

Locations

S.B.U. Sancaktepe Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

053

Identifier Type: -

Identifier Source: org_study_id