Sedation in Non-intubated Diagnostic and Therapeutic ProceduresNCT07880002
Efficacy and Safety of Nasopharyngeal Tube During Sedation
A study testing nasopharyngeal tube and regular cannula in people with Sedation in Non-intubated Diagnostic and Therapeutic Procedures and Sedation, run by International Peace Maternity and Child Health Hospital.
Trial summary
The goal of this randomized controlled study is to determine whether nasopharyngeal tube oxygenation could increase the fraction of inspired oxygen compared with standard oxygen during a sedated procedure with spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Sedation in Non-intubated Diagnostic and Therapeutic Procedures, Sedation
- What is being tested?
- nasopharyngeal tube and regular cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-60 years
- Scheduled for elective sedated gynecological surgery (including uterine dilation and curettage)
- American Society of Anesthesiologists classification (ASA) ≤II
Who cannot join
- Body mass index ≥28 or <18.5
- Mallampati classification of IV
- History of nasal surgery or nasal abnormalities
- History of coagulation disorders or nose bleeding
- Diagnosed chronic obstructive pulmonary diseases
- Upper respiratory tract infection
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- Baseline pulse oximeter (SpO2) <95%
- Allergy to drugs used during the procedure
- Psychiatric disorder or inability to comply with study investigators
- Unwillingness to provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Efficacy and Safety of Nasopharyngeal Tube During Sedation
The goal of this randomized controlled study is to determine whether nasopharyngeal tube oxygenation could increase the fraction of inspired oxygen compared with standard oxygen during a sedated procedure with spontaneous breathing. The main question it aims to answer is:
- Does nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen without increasing adverse events, compared with regular nasal cannula during sedation? Researchers will compare nasopharyngeal tube to regular nasal cannula to see if nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen.
Participants will:
- Receive regular nasal cannula or nasopharyngeal tube
- Being tested
- nasopharyngeal tube, regular cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal tubeDevice
The nasopharyngeal tube is a soft lubricated wire-reinforced tube with an internal diameter of 2.5mm, and an outer diameter of 4 mm.
regular cannulaDevice
A regular nasal cannula is a common method to deliver oxygen.
| Study group | Role | What they receive |
|---|---|---|
| nasopharyngeal tube | Experimental | After sedation, participants in the nasopharyngeal tube intervention group were received oxygen by nasopharyngeal tube placement. Receives: Device: nasopharyngeal tube |
| regular cannula | Active comparator | After sedation, participants in the regular cannula intervention group were received oxygen by regular nasal cannula. Receives: Device: regular cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fraction of inspired oxygen
The primary outcome was the fraction of inspired oxygen (FiO₂) that was continuously measured using the same anesthesia machine during sedation.
Measured: Perioperatively
Secondary outcomes (2)
Other respiration related parameters
The fraction of expired oxygen (FeO₂), partial pressure of end-tidal carbon dioxide (PetCO₂), and respiratory rate (RR); hypoxia, open airway, suction, oxygen flow, mask, intubation.
Measured: Perioperatively
Adverse events
hypotension, bradycardia, mucosal injury, epistaxia, rhinalgia, nausea, cough
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in Non-intubated Diagnostic and Therapeutic ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880002
- Sponsor's protocol ID
- InternationalPMCHH
- Other IDs
- Shanghai Jiaotong University
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No