The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation

NCT05962125 | Completed DMC

• 1 other identifier: E2023069
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Power; Alveolar Recruitment Maneuvers; Protective Ventilation; Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• Intraoperative mechanical power

  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\[Pplat - PEEP\] + \[Ppeak - Pplat\])

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

Secondary Outcomes (23)

• Mechanical power during capnoperitoneum

  30 minutes after starting carbon dioxide pneumoperitoneum

• Accumulative mechanical power (AMP)

  During intraoperative mechanical ventilation, an average of 3 hours

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

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

• Shunt fraction

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

• Dead space rate

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

Study Arms (3)

periodic alveolar recruitment maneuvers (PARM) alone

EXPERIMENTAL

Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator.

Other: periodic alveolar recruitment maneuvers

positive end-expiratory pressure (PEEP) alone

ACTIVE COMPARATOR

PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O.

Other: positive end-expiratory pressure

a combination of PEEP and PARM

ACTIVE COMPARATOR

Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O.

Other: periodic alveolar recruitment maneuvers; Other: positive end-expiratory pressure

Interventions

periodic alveolar recruitment maneuvers OTHER

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

a combination of PEEP and PARM; periodic alveolar recruitment maneuvers (PARM) alone

positive end-expiratory pressure OTHER

a PEEP of 6 to 8 cm H2O

a combination of PEEP and PARM; positive end-expiratory pressure (PEEP) alone

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Hong Li, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 27, 2023
• Study Start: August 21, 2023
• Primary Completion: November 8, 2023
• Study Completion: December 31, 2023
• Last Updated: December 3, 2024

Record last verified: 2023-09

Locations

CN (1)