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Completed

NCT Number: NCT02848118

Capnography Monitoring in the Bronchoscopic Sedation

Procedure sedation of flexible bronchoscopy (FB) comforts patients undergoing FB. Hypoventilation during FB is a concern. The investigators investigate the feasibility of monitoring capnography in FB sedation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Gung Medical Fundation

Taoyuan, 333, Taiwan

About this study

Patients undergoing flexible bronchoscopy (FB) experience procedure-related symptoms. Current guidelines of FB recommend sedation to all patients undergoing FB, except when there are contraindications. Propofol or benzodiazepines plus an opioid are the common combination used to improve patient tolerance and satisfaction during FB. However, controversy about combining propofol and opioids persists because of the risk of over-sedation and cardiopulmonary depression.

While transition from alert into sedation during induction, like sleep, the respiratory drive and muscle tone of respiratory muscle and upper airway attenuate, which contribute hypoventilation and upper airway collapse, and further hypoxemia. Detection of cardiopulmonary depression traditionally has relied on continuous monitoring of heart rate, respiratory rate, and oxygen saturation. However, it has been shown that these monitors could not recognize hypoventilation early. Similar with other published data, around 40% of hypoxemia event occurred during FB sedation in our hospital. Further analysis of our data revealed around 15% event occurred during sedative induction.

Capnography is the noninvasive measurement of the partial pressure of carbon dioxide (CO2) from the airway during ventilation. The maximum partial pressure of CO2 obtained at the end of an exhaled breath is referred to as end-tidal CO2 (EtCO2). Studies have revealed the waveform analysis of capnography can provide early warning for prehypoxic respiratory depression in patients undergoing procedure sedation in emergency department and gastrointestinal endoscopy. Therefore, capnography can serve as a real-time measure of ventilatory status of sedative patients and the physicians could intervene before the occurrence of hypoxemia. Based on the advantage of non-invasive and real-time property of EtCO2 monitored by capnography, the investigators plan to conduct a clinical trial to evaluate if hypoxemia could be reduced by capnography of EtCO2 monitor during induction of FB sedation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing elective bronchoscopy and sedation

Exclusion criteria

  • Age less than 18 years
  • American Society of Anaesthesiologists (ASA) physical status classification IV or V
  • Mallampati score of 4
  • Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
  • Body mass index more than 42 in males or 35 in females
  • Neurologic disorders or other conditions contributing to difficulty in assessing response
  • Forced expiratory vital capacity (FVC) less than 15 ml/kg body weight, forced expiratory volume in one second (FEV1) less than 1000 ml, or FEV1/FVC less than 35%
  • Chronic use of opioid drugs
  • Pregnancy
  • Patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products

Treatment and study plan

A nasal-oral cannula of capnography

Device

After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.

Other names: End-tidal CO2

Observer Assessment of Alertness and Sedation scale

Other

After propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients.

Other names: OAAS

Primary outcomes

  1. Hypoxemia

    Time frame: 60 minutes

    Oxyhemoglobin saturation less than 90% with any duration after induction to patient recovery.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 60 minutes

    A 10cm visual analogue scale about how the patients fell about the bronchoscopy

  2. Patient cooperation accessed by bronchoscopists

    Time frame: 60 minutes

    A 10cm visual analogue scale about how the bronchoscopists fell the cooperation of patients during bronchoscopy.

  3. Induction time

    Time frame: 10 minutes

    The length of time for achieving adequate sedative depth to start bronchoscopy

  4. Procedure time

    Time frame: 30 minutes

    The length of time for complete bronchoscopy

  5. Propofol dosage

    Time frame: 60 minutes

    the dose of propofol for induction and whole bronchoscopy

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Capnography Monitoring the Hypoventilation During Bronchoscopic Sedation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2016
Registry last updated
Mar 9, 2017

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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