Endtidalcarbondioxide Monitoring

Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical Advantage?

Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical Advantage?

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Dysfunction
• Intervention / Treatment: Device: Capnostream 20p / Coviden; Device: Rutine monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul, Turkey, 34785
    • S.B.U. Sancaktepe Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Capnostream 20p / Coviden; The special nasal canule is used for detection carbondioxide from breathe of patients
Active Comparator: Control Group; Rutine monitorization will be performed to control group of patients.	Device: Rutine monitoring; peripheric Oxygen saturation is monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early detection of adverse events	early detection of adverse events in patients who underwent sedation during gastrointestinal endoscopic intervention in the endoscopy unit	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of recovery period	Fast-tracking recovery score is eveluaed for quality of recovery period	120 minutes
Patients satisfaction	Patients is called for eveluating for their satisfaction. (1:not satisfied at all, 2: not satisfied, 3: neutral, 4:satisfied, 5: very satisfied).	24 hours

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Study Director: Nurten Bakan, doctor, Ministry of Health University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No