NCT02848118

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 18, 2015

Last Update Submit

March 8, 2017

Conditions

Hypoventilation

Keywords

Hypoventilationcapnographybronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Hypoxemia

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

    60 minutes

Secondary Outcomes (5)

  • Patient satisfaction

    60 minutes

  • Patient cooperation accessed by bronchoscopists

    60 minutes

  • Induction time

    10 minutes

  • Procedure time

    30 minutes

  • Propofol dosage

    60 minutes

Study Arms (2)

A nasal-oral cannula of capnography

EXPERIMENTAL

Start bronchoscopy when the nasal-oral capnography shows hypoventilation during bronchoscopic sedation.

Device: A nasal-oral cannula of capnography

Sedation scale

ACTIVE COMPARATOR

Start bronchoscopy when Observer Assessment of Alertness and Sedation scale (OAAS)=3\~2 during bronchoscopic sedation.

Other: Observer Assessment of Alertness and Sedation scale

Interventions

A nasal-oral cannula of capnographyDEVICE

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

Also known as: End-tidal CO2
A nasal-oral cannula of capnography
Observer Assessment of Alertness and Sedation scaleOTHER

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

Also known as: OAAS
Sedation scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective bronchoscopy and sedation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Gung Medical Fundation

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

  • Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.

    PMID: 23638141BACKGROUND

  • Soto RG, Fu ES, Vila H Jr, Miguel RV. Capnography accurately detects apnea during monitored anesthesia care. Anesth Analg. 2004 Aug;99(2):379-82, table of contents. doi: 10.1213/01.ANE.0000131964.67524.E7.

    PMID: 15271710BACKGROUND

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Lun Lo, MD

    Chang Gung Medical fundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 18, 2015

First Posted

July 28, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

TW(1)