Integrated Pulmonary Index Monitoring on the Incidence of Hypoxemia in Elderly Patients With Painless Colonoscopy

NCT06987630 | Completed DMC

• 1 other identifier: KY-20241226001-01
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypoxia

Keywords

Elderly patients; Colonoscopy; Propofol

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  the number of patients experiencing low blood pressure

  Perioperative

Secondary Outcomes (1)

• Adverse reactions (dizziness, nausea, vomiting, etc.)

  Perioperative

Study Arms (2)

P group

EXPERIMENTAL

Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min, monitor the integrated pulmonary index and SpO2.

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,

Interventions

monitor integrated pulmonary index（IPI） and take appropriate measures DEVICE

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.

P group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

Study Sites (1)

The First People's Hospital of Lianyungang City

Lianyungang, Jiangsu, 222000, China

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 31, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)