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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: monitor integrated pulmonary index（IPI） and take appropriate measures

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222000
      • The First People's Hospital of Lianyungang City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P group; 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; 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.
No Intervention: C group; Nasal cannula oxygen inhalation, oxygen flow rate 3-4L/min,monitor the SpO2,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	the number of patients experiencing low blood pressure	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions (dizziness, nausea, vomiting, etc.)	The number of adverse reactions (dizziness, nausea, vomiting, etc.)	Perioperative

Collaborators and Investigators

• Sponsor: The First People's Hospital of Lianyungang

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: May 15, 2025
• First Posted (Actual): May 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Elderly patients; Colonoscopy; Propofol
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: KY-20241226001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No