Early Postoperative AtelectasisNCT06554678
THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study
A study testing Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） and conventional oxygen mask in people with Early Postoperative Atelectasis, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Postoperative Atelectasis
- What is being tested?
- Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） and conventional oxygen mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Multiple polyps resection, ESD(Endoscopic Submucosal Dissection) , EMR(Endoscopic Mucosal Resection), enteroscopy and other gastrointestinal endoscopic diagnosis and treatment were performed
- The duration of anesthesia is more than 30 minutes, that is, from induction to withdrawal of anesthesia
- ASA(American Society of Anesthesiologists) ≤ II 4.18kg/m2<BMI<30 kg/m2
- 5.Informed consent, voluntary participation in the experiment, and signed by the subject informed consent
Who cannot join
- ASA classification ≥ III;
- History of previous lung or nasal surgery;
- History of chronic obstructive pulmonary disease (COPD) or restrictive lung disease;
- History of obstructive sleep apnea syndrome;
- History of upper airway obstruction;
- History of head and neck radiation therapy;
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- Significant nasal septum deviation;
- Active infection (defined as a white blood cell count >10*10^9 or a body temperature >38°C);
- Gastrointestinal perforation;
- Combined use of other anesthetic methods or inhalation anesthetics outside of non-intubated intravenous anesthesia;
- Concurrent other medical procedures besides the prescribed gastrointestinal endoscopic procedures, such as ERCP(Endoscopic Retrograde Cholangiopancreatography);
- Severe communication disorders due to conditions like severe hearing impairment or dementia;
- Disagreement with participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy.
- Conditions
- Early Postoperative Atelectasis
- Being tested
- Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）, conventional oxygen mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）Procedure or surgery
Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）
conventional oxygen maskProcedure or surgery
conventional oxygen mask
| Study group | Role | What they receive |
|---|---|---|
| Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） group | Experimental | Not described Receives: Procedure: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） |
| conventional oxygen mask group | Active comparator | Not described Receives: Procedure: conventional oxygen mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atelectasis
Lung ultrasound examination was performed before anesthesia induction (T1) and immediately after surgery (T2), and patients' modified lung ultrasound score (LUSS) was recorded.
Measured: Early postoperative period
Secondary outcomes (12)
Diaphragm movement
Measured: Before anesthesia induction (T1) and immediately after surgery (T2)
Heart rate (HR)
Throughout the procedure, the heart rate (HR) was continuously monitored.
Measured: Baseline，during surgery and arrived at PACU
Pulse oxygen saturation (SpO2)
Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.
Measured: Baseline，during surgery and arrived at PACU
Mean blood pressure (MBP)
Throughout the procedure, the mean blood pressure (MBP) was measured at 3-minute intervals.
Measured: Baseline，during surgery and arrived at PACU
Patient satisfaction levels
The patients express their satisfaction with procedures on a numerical rating scale, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.
Measured: After the patient is awake
Endoscopist satisfaction levels
The Endoscopists express their satisfaction with procedures on a numerical rating scale, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.
Measured: After the surgery
Adverse Events (AEs) During Surgery and PACU
radycardia; Hypertension; Hypotension; Hypoxemia; Aspiration and Regurgitation
Measured: During surgery and PACU
Adverse Events (AEs) Within 7 Days Post-Operatively
Fever; Cough and Sputum Production; Antibiotic Usage
Measured: Within 7 days after surgery
PACU Stay Duration
Measured: The time from entering PACU to improving Aldrete score ≥9
Length of Hospital Stay
Measured: The time from admission to discharge
Dosage of propofol
Measured: During surgery
Dosage of remifentanil
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start18 Feb 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Postoperative AtelectasisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Gao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554678
- Sponsor's protocol ID
- 2024ky033
- Status last verified
- Oct 2024
- First submitted
- 12 Aug 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song S, Meng M, Han Y, Wang X, Liu X, Gao J. Effect of transnasal humidified rapid insufflation ventilator exchange on early postoperative atelectasis in patients undergoing prolonged non-intubated anesthesia: a randomized clinical trial. BMC Anesthesiol. 2026 Jun 10. doi: 10.1186/s12871-026-03989-4. Online ahead of print.
PubMed 42265606
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE Improves Early Postoperative Atelectasis in Long-Time Non-Tracheal Intubation Anesthesia for Gastrointestinal Endoscopy: a Clinical Study
- ClinicalTrials.gov ID
- NCT06554678
- Acronym / sponsor ID
- 2024ky033
- Conditions
- Early Postoperative Atelectasis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the clinical effect of THRIVE in improving early postoperative atelectasis in patients undergoing long-term non-intubated anesthesia gastrointestinal endoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） group | Experimental | Procedure: Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） |
| conventional oxygen mask group | Active comparator | Procedure: conventional oxygen mask |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Multiple polyps resection, ESD(Endoscopic Submucosal Dissection) , EMR(Endoscopic Mucosal Resection), enteroscopy and other gastrointestinal endoscopic diagnosis and treatment were performed
- The duration of anesthesia is more than 30 minutes, that is, from induction to withdrawal of anesthesia
- ASA(American Society of Anesthesiologists) ≤ II 4.18kg/m2<BMI<30 kg/m2
- 5.Informed consent, voluntary participation in the experiment, and signed by the subject informed consent
Key exclusion criteria (13 listed)
- ASA classification ≥ III;
- History of previous lung or nasal surgery;
- History of chronic obstructive pulmonary disease (COPD) or restrictive lung disease;
- History of obstructive sleep apnea syndrome;
- History of upper airway obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal humidified rapid insufflation ventilatory exchange（THRIVE）Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） | Procedure or surgery | Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） group |
| conventional oxygen maskconventional oxygen mask | Procedure or surgery | conventional oxygen mask group |
Primary outcome
Incidence of atelectasis
Time frame: Early postoperative period
Lung ultrasound examination was performed before anesthesia induction (T1) and immediately after surgery (T2), and patients' modified lung ultrasound score (LUSS) was recorded.
12 secondary outcomes
Diaphragm movement
Time frame: Before anesthesia induction (T1) and immediately after surgery (T2)
Heart rate (HR)
Time frame: Baseline，during surgery and arrived at PACU
Pulse oxygen saturation (SpO2)
Time frame: Baseline，during surgery and arrived at PACU
Mean blood pressure (MBP)
Time frame: Baseline，during surgery and arrived at PACU
Patient satisfaction levels
Time frame: After the patient is awake
Endoscopist satisfaction levels
Time frame: After the surgery
Adverse Events (AEs) During Surgery and PACU
Time frame: During surgery and PACU
Adverse Events (AEs) Within 7 Days Post-Operatively
Time frame: Within 7 days after surgery
PACU Stay Duration
Time frame: The time from entering PACU to improving Aldrete score ≥9
Length of Hospital Stay
Time frame: The time from admission to discharge
Dosage of propofol
Time frame: During surgery
Dosage of remifentanil
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 42265606Song S, Meng M, Han Y, Wang X, Liu X, Gao J. Effect of transnasal humidified rapid insufflation ventilator exchange on early postoperative atelectasis in patients undergoing prolonged non-intubated anesthesia: a randomized clinical trial. BMC Anesthesiol. 2026 Jun 10. doi: 10.1186/s12871-026-03989-4. Online ahead of print.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal humidified rapid insufflation ventilatory exchange（THRIVE） and conventional oxygen mask in people with Early Postoperative Atelectasis, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atelectasis (time frame: Early postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.