HypoxiaNCT06987630
Integrated Pulmonary Index Monitoring on the Incidence of Hypoxemia in Elderly Patients With Painless Colonoscopy
A study testing monitor integrated pulmonary index（IPI） and take appropriate measures in people with Hypoxia, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
The purpose of this clinical trial is to integrated pulmonary index to see if there is an effect on the incidence of hypoxemia during painless colonoscopy in older patients. Does composite pulmonary index monitoring reduce the incidence of hypoxemia? Is there a relationship between the value of the integrated… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- monitor integrated pulmonary index（IPI） and take appropriate measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients who were selected for non-intubated painless colonoscopy;
- Age≥ 65 years;
- American Society of Anesthesiologists (ASA) grade I~III;
- Conscious, no cognitive dysfunction and other mental illnesses;
- Voluntarily participate in this study and sign the informed consent form
Who cannot join
- Patients with severe circulatory system diseases, respiratory diseases, and central nervous system diseases;
- Patients with severe abnormal liver and kidney function;
- Those who are allergic to any of the drugs used in the study;
- Participated in other clinical studies within the last 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222000
About this study
Official title: Effect of Continuous Integrated Pulmonary Index Monitoring on the Incidence of Hypoxemia in Elderly Patients With Painless Colonoscopy
The purpose of this clinical trial is to integrated pulmonary index to see if there is an effect on the incidence of hypoxemia during painless colonoscopy in older patients.
Does composite pulmonary index monitoring reduce the incidence of hypoxemia? Is there a relationship between the value of the integrated pulmonary index and the patient's pulse oximetry? Continuous monitoring of the integrated pulmonary index in the experimental group was compared with the control group (no detection of the composite lung index) to see if continuous monitoring of the composite pulmonary index could reduce the incidence of hypoxemia in elderly patients.
Read more
Participants will:
Oxygen is provided through the nasal cannula, and respiratory parameters (end-tidal carbon dioxide partial pressure (PetCO2), pulse rate [PR], oxygen saturation (SpO2), and respiratory rate (RR) are obtained. The monitor calculates a integrated pulmonary index value (1-10) through mathematical operations.Different measures are taken according to different composite lung indexes, such as when the IPI is ≤6, the patient's jaw is immediately lifted, the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated.
Record their vital signs.
Read the detailed description
This study is a single-center, double-blind, prospective, randomized controlled trial. In this experiment, all patients who met the inclusion criteria and did not meet any of the exclusion criteria were divided into SpO2 group (group C) and IPI group (group P) according to 1:1 by computer random number method. After entering the examination room, the two groups of patients signed the informed consent form and underwent vital sign monitoring. Anesthesia process: propofol 1~ 2mg/kg, Intraoperatively, vasoactive drugs such as norepinephrine or ephedrine are used as needed. Group C: SpO2 of the patient's right index finger was monitored with a fingertip oximeter. When the SpO2 decreases by 5% compared with the basic SpO2, the patient's jaw is immediately propped up, and the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. Group P: Fingertip oximetry was used to monitor the SpO2 of the patient's right index finger, and the patient's PETCO2 was monitored with nasal cannula bypass, and when the IPI was ≤6, The patient's jaw is immediately lifted, the oxygen flow rate is increased to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. Vital signs (blood pressure, heart rate, pulse oximetry or IPI), medication (propofol or vasoactive), anesthesia time and adverse events were recorded in both groups.
- Conditions
- Hypoxia
- Being tested
- monitor integrated pulmonary index（IPI） and take appropriate measures
- Keywords
- Elderly patients, Colonoscopy, Propofol
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitor integrated pulmonary index（IPI） and take appropriate measuresDevice
When the IPI is ≤ 6, the patient's jaw is immediately lifted, the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated.
| Study group | Role | What they receive |
|---|---|---|
| P group | Experimental | Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min, monitor the integrated pulmonary index and SpO2. Receives: Device: monitor integrated pulmonary index（IPI） and take appropriate measures |
| C group | No intervention | Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min,monitor the SpO2, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
the number of patients experiencing low blood pressure
Measured: Perioperative
Secondary outcomes (1)
Adverse reactions (dizziness, nausea, vomiting, etc.)
The number of adverse reactions (dizziness, nausea, vomiting, etc.)
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jun 2025
- Primary completion1 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987630
- Sponsor's protocol ID
- KY-20241226001-01
- Status last verified
- Nov 2025
- First submitted
- 5 May 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Integrated Pulmonary Index Monitoring on the Incidence of Hypoxemia in Elderly Patients With Painless Colonoscopy
- ClinicalTrials.gov ID
- NCT06987630
- Acronym / sponsor ID
- KY-20241226001-01
- Conditions
- Hypoxia
- Keywords
- Elderly patients, Colonoscopy, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 23 May 2025 (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.
The purpose of this clinical trial is to integrated pulmonary index to see if there is an effect on the incidence of hypoxemia during painless colonoscopy in older patients.
Does composite pulmonary index monitoring reduce the incidence of hypoxemia? Is there a relationship between the value of the integrated pulmonary index and the patient's pulse oximetry? Continuous monitoring of the integrated pulmonary index in the experimental group was compared with the control group (no detection of the composite lung index) to see if continuous monitoring of the composite pulmonary index could reduce the incidence of hypoxemia in elderly patients.
Participants will:
Oxygen is provided through the nasal cannula, and respiratory parameters (end-tidal carbon dioxide partial pressure (PetCO2), pulse rate [PR], oxygen saturation (SpO2), and respiratory rate (RR) are obtained. The monitor calculates a integrated pulmonary index value (1-10) through mathematical operations.Different measures are taken according to different composite lung indexes, such as when the IPI is ≤6, the patient's jaw is immediately lifted, the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated.
Record their vital signs.
Detailed description
This study is a single-center, double-blind, prospective, randomized controlled trial. In this experiment, all patients who met the inclusion criteria and did not meet any of the exclusion criteria were divided into SpO2 group (group C) and IPI group (group P) according to 1:1 by computer random number method. After entering the examination room, the two groups of patients signed the informed consent form and underwent vital sign monitoring. Anesthesia process: propofol 1~ 2mg/kg, Intraoperatively, vasoactive drugs such as norepinephrine or ephedrine are used as needed. Group C: SpO2 of the patient's right index finger was monitored with a fingertip oximeter. When the SpO2 decreases by 5% compared with the basic SpO2, the patient's jaw is immediately propped up, and the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. Group P: Fingertip oximetry was used to monitor the SpO2 of the patient's right index finger, and the patient's PETCO2 was monitored with nasal cannula bypass, and when the IPI was ≤6, The patient's jaw is immediately lifted, the oxygen flow rate is increased to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. Vital signs (blood pressure, heart rate, pulse oximetry or IPI), medication (propofol or vasoactive), anesthesia time and adverse events were recorded in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P group | Experimental | Device: monitor integrated pulmonary index（IPI） and take appropriate measuresNasal cannula oxygen inhalation, oxygen flow rate 3-4L/min, monitor the integrated pulmonary index and SpO2. |
| C group | No intervention | –Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min,monitor the SpO2, |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients who were selected for non-intubated painless colonoscopy;
- Age≥ 65 years;
- American Society of Anesthesiologists (ASA) grade I~III;
- Conscious, no cognitive dysfunction and other mental illnesses;
- Voluntarily participate in this study and sign the informed consent form
Key exclusion criteria (4 listed)
- Patients with severe circulatory system diseases, respiratory diseases, and central nervous system diseases;
- Patients with severe abnormal liver and kidney function;
- Those who are allergic to any of the drugs used in the study;
- Participated in other clinical studies within the last 3 months
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 |
|---|---|---|
| monitor integrated pulmonary index（IPI） and take appropriate measuresWhen the IPI is ≤ 6, the patient's jaw is immediately lifted, the oxygen flow rate increases to 6L·min-1, and if the SpO2 continues to decrease by <90%, the anesthesia mask is pressurized and ventilated. | Device | P group |
Primary outcome
Incidence of hypotension
Time frame: Perioperative
the number of patients experiencing low blood pressure
1 secondary outcome
Adverse reactions (dizziness, nausea, vomiting, etc.)
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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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 monitor integrated pulmonary index（IPI） and take appropriate measures in people with Hypoxia, run by The First People's Hospital of Lianyungang 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 1 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 hypotension (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.