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Completed

NCT Number: NCT04177927

Endtidalcarbondioxide Monitoring

Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical Advantage?

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.B.U. Sancaktepe Education and Research Hospital

Istanbul, 34785, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Capnostream 20p / Coviden

Device

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

Rutine monitoring

Device

peripheric Oxygen saturation is monitored.

Primary outcomes

  1. early detection of adverse events

    Time frame: 30 minutes

    early detection of adverse events in patients who underwent sedation during gastrointestinal endoscopic intervention in the endoscopy unit

Secondary outcomes

  1. quality of recovery period

    Time frame: 120 minutes

    Fast-tracking recovery score is eveluaed for quality of recovery period

  2. Patients satisfaction

    Time frame: 24 hours

    Patients is called for eveluating for their satisfaction. (1:not satisfied at all, 2: not satisfied, 3: neutral, 4:satisfied, 5: very satisfied).

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

Does Endtidalcarbondioxide Monitoring in Gastrointestinal Endoscopy Have a Clinical Advantage?

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Oct 8, 2021

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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