Skip to main content
OpenTrials
Completed

NCT Number: NCT05962125

The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation

The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mechanical Power Alveolar Recruitment Maneuvers Postoperative Pulmonary Complications Protective Ventilation

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.
  • Had an intermediate risk of developing postoperative pulmonary complications.
  • Pulse oxygen saturation in room air ≥ 94%.
  • Aged 60 to 80 years.

Exclusion criteria

  • 1. Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.
  • Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV or higher.
  • Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.

Treatment and study plan

periodic alveolar recruitment maneuvers

Other

A stepwise increment of tidal volume was used for each ARM.

positive end-expiratory pressure

Other

a PEEP of 6 to 8 cm H2O

Primary outcomes

  1. Intraoperative mechanical power

    Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery

    Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat])

Secondary outcomes

  1. Mechanical power during capnoperitoneum

    Time frame: 30 minutes after starting carbon dioxide pneumoperitoneum

    mechanical power, J/min

  2. Accumulative mechanical power (AMP)

    Time frame: During intraoperative mechanical ventilation, an average of 3 hours

    Accumulative mechanical power (AMP) = AMP before capnoperitoneum + AMP during capnoperitoneum + AMP after capnoperitoneum. Accumulative mechanical power before capnoperitoneum = mechanical power before capnoperitoneum (10 min after mechanical ventilation) × the length of mechanical ventilation before capnoperitoneum. Accumulative mechanical power during capnoperitoneum = mechanical power during capnoperitoneum (30 min after mechanical ventilation) × the length of mechanical ventilation during capnoperitoneum. Accumulative mechanical power after capnoperitoneum (after the end of capnoperitoneum) = mechanical power after capnoperitoneum (10 min after the end of capnoperitoneum) × the length of mechanical ventilation after capnoperitoneum

  3. An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)

    Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery

    P/F ratio, mmHg

  4. Shunt fraction

    Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery

    Shunt fraction, %

  5. Dead space rate

    Time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery

    Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.

  6. Rate of respiratory failure at post-anesthesia care unit (PACU)

    Time frame: Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU

    Respiratory failure: PaO2 < 60 mmHg or pulse oxygen saturation (SpO2) < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.

  7. Soluble advanced glycation end products receptor (sRAGE)

    Time frame: 20 minutes after entering PACU

    The concentration of plasma sRAGE, pg/ml

  8. Clara cell protein 16 (CC16)

    Time frame: 20 minutes after entering PACU

    The concentration of plasma CC16, ng/ml

  9. Surfactant Protein D (SP-D)

    Time frame: 20 minutes after entering PACU

    The concentration of plasma SP-D, ug/ml

  10. Interleukin 6 (IL-6)

    Time frame: 20 minutes after entering PACU

    The concentration of plasma IL-6, pg/ml

  11. Rate of postoperative respiratory failure

    Time frame: Time Frame: Day 0 to 3 after surgery

    Respiratory failure: PaO2 < 60 mmHg or SpO2 < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.

  12. Rate of sustained hypoxaemia

    Time frame: Day 0 to 3 after surgery

    Sustained hypoxaemia, hypoxaemia at any two consecutive days; hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5%.

  13. Postoperative pulmonary complications score

    Time frame: Day 0 to 3 after surgery

    Postoperative pulmonary complications score: Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).

  14. Postoperative hospitalization days

    Time frame: Day 0 to 30 after surgery

    The duration between the operation date and the actual discharge date.

  15. Death from any cause

    Time frame: Day 0 to 30 after surgery

    Intraoperative or postoperative death from any cause

  16. Rate of intraoperative hypotension

    Time frame: During intraoperative mechanical ventilation, an average of 3 hours

    Intraoperative hypotension, mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes.

  17. Rate of need for vasoconstrictors

    Time frame: During intraoperative mechanical ventilation, an average of 3 hours

    MAP < 60 mmHg and using any vasoconstrictors.

  18. Rate of intraoperative hypoxemia

    Time frame: During intraoperative mechanical ventilation, an average of 3 hours

    Intraoperative hypoxemia, SpO2 ≤ 92% lasting more than 3 minutes.

  19. Rate of intraoperative bradycardia

    Time frame: During intraoperative mechanical ventilation, an average of 3 hours

    Intraoperative bradycardia, heart rate ≤ 50 bpm and the decrease of heart rate from the basic value ≥ 20% lasting more than 3 minutes.

  20. Rate of pneumothorax

    Time frame: During surgery or within 7 days after surgery

    Pneumothorax, air in the pleural space with no vascular bed surrounding the visceral pleura.

  21. Rate of pleural effusion

    Time frame: within 7 days after surgery

    Pleural effusion, diagnosed according to previous literature (Doi: 10.1097/EJA.0000000000000118).

  22. Unexpected admission to ICU

    Time frame: within 30 days after surgery

    It does not include the patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness.

  23. Tumor Necrosis Factor alpha (TNF-α)

    Time frame: 20 minutes after entering PACU

    TNF-α, pg/ml.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Effects of Three Open-lung Strategies on Respiratory Function and Lung Injury in Protective Ventilation for Laparoscopic Anterior Resection: a Randomized Controlled Trial

Acronym: REMAIN-2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.