Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Effect of Transnasal Microstream Capnography on Incidence of Hypoxemia During Emergence From General Anesthesia in Elderly Patients After Abdominal Surgery: A Prospective Randomised Controlled Trial
調査の概要
詳細な説明
Study Title:
Effect of Transnasal Microstream End-Tidal Carbon Dioxide Monitoring on the Incidence of Postoperative Hypoxemia in Elderly Patients Undergoing Laparoscopic Surgery under General Anesthesia with Endotracheal Intubation: A Prospective, Randomized Controlled Study
Principal Investigator: Wu Jianbo Department: Anesthesiology and Perioperative Medicine
Background & Objective:
Postoperative hypoxemia is a common respiratory complication in the post-anesthesia care unit (PACU). Conventional pulse oximetry (SpO₂) has a delayed response to hypoventilation, especially during supplemental oxygen therapy. This study aims to investigate whether adding transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring in the PACU reduces the incidence of hypoxemia in elderly patients after laparoscopic surgery under general anesthesia.
Study Design:
Prospective, randomized, controlled, interventional study.
Participants:
324 elderly patients (age 65-80 years, ASA I-III, BMI 18-30 kg/m²) scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation.
Interventions:
Control group (n=162): Routine monitoring with SpO₂ and clinical observation; oxygen delivery at 2 L/min via sampling line without EtCO₂ monitoring.
Experimental group (n=162): Same oxygen delivery plus continuous real-time transnasal microstream EtCO₂ monitoring.
Primary Outcome:
Incidence of postoperative hypoxemia (SpO₂ < 90% for >15 seconds) after extubation in the PACU.
Secondary Outcomes:
Incidence of severe hypoxemia (SpO₂ < 85% for >15 seconds) Lowest SpO₂ during PACU stay Vital signs at predefined time points
PACU length of stay (Steward Recovery Score ≥ 4)
Other adverse events (e.g., nausea, vomiting, agitation, shivering)
Safety Monitoring:
Device-related adverse events (nasal irritation, bleeding), respiratory events (bradypnea, apnea, airway obstruction), and serious adverse events (e.g., need for advanced airway, cardiovascular events) will be recorded and managed according to a stepwise intervention protocol.
Randomization and Blinding:
1:1 randomization using block randomization (SAS 9.4) with allocation concealment (sealed, opaque envelopes). Partial blinding: participants, outcome assessors, and statisticians blinded; anesthesiologists/operators unblinded.
Sample Size Calculation:
Based on pilot data (expected hypoxemia rate: 33% in control vs. 18% in experimental group), α=0.05, power=80%, plus 20% dropout → 162 patients per group (total N=324).
Statistical Analysis:
SPSS 22.0 will be used. Continuous variables (normal distribution) will be compared using t-test; non-normally distributed variables using Mann-Whitney U test. Categorical variables (e.g., hypoxemia incidence) will be compared using chi-square or Fisher's exact test.
Expected Significance:
This study will provide high-level evidence on whether transnasal microstream EtCO₂ monitoring in the PACU can enhance respiratory safety in elderly patients recovering from laparoscopic surgery, potentially reducing hypoxemia and related complications.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jianbo WU
- 電話番号：18560083793
- メール：jianbowu@sdu.edu.cn
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 65-80 years;
- ASA physical status I-III;
- BMI 18-30 kg/m²;
- Participants scheduled for elective laparoscopic surgery under general anesthesia with endotracheal intubation;
- Willing to participate in the study and provide written informed consent
Exclusion Criteria:
- Patients with nasal bleeding, nasal mucosal injury, nasal cavity occupancy, or other conditions that preclude transnasal carbon dioxide monitoring;
- Patients undergoing emergency surgery;
- Participants requiring postoperative assisted ventilation via endotracheal intubation or tracheostomy;
- Presence of any disease or condition that may cause abnormal end-tidal carbon dioxide waveforms or abnormal baseline pulse oximetry (e.g., congenital heart disease or chronic lung disease);
- Severe cardiac insufficiency (≤4 Metabolic Equivalents [MetS]);
- Severe renal insufficiency (acute kidney injury [AKI] or chronic kidney disease [CKD] stage 4 or higher);
- Severe hepatic insufficiency (Child-Pugh class C or worse);
- Allergy to study medications;
- Daily alcohol intake ≥60 grams;
- History of psychiatric disorders such as depression, severe central nervous system depression, Parkinson's disease, basal ganglion lesions, schizophrenia, epilepsy, Alzheimer's disease;
- Participation in another related clinical study within the past 3 months.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Control Group (Routine Monitoring Group)
After endotracheal extubation, the sampling end of the sampling line is placed between the patient's mouth and nose, and oxygen is delivered at 2 L/min via the sampling line.
The patient receives only routine monitoring (including continuous pulse oximetry and clinical observation) and is not connected to the end-tidal carbon dioxide (EtCO₂) monitoring device.
|
After extubation, the sampling line is placed between the patient's mouth and nose to deliver oxygen at 2 L/min.
The patient receives routine monitoring including continuous pulse oximetry (SpO₂) and clinical observation, but is not connected to the EtCO₂ monitoring device.
|
|
実験的：Experimental Group (EtCO₂ Monitoring Group)
After endotracheal extubation, the sampling end of the sampling line is placed between the patient's mouth and nose, and oxygen is delivered at 2 L/min via the sampling line.
At the same time, the sampling line is connected to the monitor to initiate continuous real-time transnasal microstream end-tidal carbon dioxide monitoring.
|
After extubation, the sampling line is placed between the patient's mouth and nose to deliver oxygen at 2 L/min.
The sampling line is connected to a patient monitor (RespArrayTM) to initiate continuous real-time transnasal microstream end-tidal carbon dioxide (EtCO₂) monitoring throughout the post-anesthesia care unit (PACU) stay.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of post-extubation hypoxemia (SpO₂ < 90% for >15 seconds)
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Closely monitor vital signs, and record the number of episodes of hypoxemia (defined as SpO₂ < 90% lasting for >15 seconds) following tracheal extubation after the patient is transferred from the operating room to the PACU.more
than 15 seconds
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of severe hypoxemia: proportion of patients with SpO₂ < 85% lasting > 15 seconds
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Closely monitor the patient's vital signs, and record the proportion of patients with severe hypoxemia (SpO₂ < 85% lasting >15 seconds) following tracheal extubation after transfer from the operating room to the PACU
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
|
Lowest SpO₂ value during PACU stay Lowest SpO₂ value during PACU stay Lowest SpO₂ value during PACU stay
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Observe and record the lowest SpO₂ value during the patient's stay in the PACU
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
|
PACU length of stay
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
time from entering the PACU until achieving a Steward recovery score >4, meeting the criteria for discharge
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
|
Other adverse events
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Record adverse events occurring during the entire PACU stay
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
|
Record the changes in heart rate following the patient's admission to the PACU
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Record the patient's heart rate at T0 (on PACU admission), T1 (1 min post-extubation), T2 (5 min post-extubation), T3 (10 min post-extubation), T4 (15 min post-extubation), T5 (20 min post-extubation), and T6 (on PACU discharge)
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
|
Record the patient's blood pressure after admission to the PACU
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Record the patient's blood pressure values at T0 (on PACU admission), T1 (1 min post-extubation), T2 (5 min post-extubation), T3 (10 min post-extubation), T4 (15 min post-extubation), T5 (20 min post-extubation), and T6 (on PACU discharge)
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
|
Record the changes in the patient's SpO₂ values after admission to the PACU
時間枠：During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
Record the patient's SpO₂ values at T0 (on PACU admission), T1 (1 min post-extubation), T2 (5 min post-extubation), T3 (10 min post-extubation), T4 (15 min post-extubation), T5 (20 min post-extubation), and T6 (on PACU discharge)
|
During the period in the post-anesthesia care unit (PACU) (up to 1 days)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jianbo WU, Doctoral、Shandong First Medical University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- YXLL-KY-2026(147)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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