The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation

Postoperative Pulmonary Complications Clinical Trial

— REMAIN-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05962125
• Other study ID #: E2023069
• Status: Completed
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.

2. Had an intermediate risk of developing postoperative pulmonary complications.

3. Pulse oxygen saturation in room air = 94%.

4. 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.

2. 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.

6. Intracranial hypertension. 7. Body mass index (BMI) =30 kg/m2. 8. Were involved in other interventional studies.

Related Conditions & MeSH terms

• Mechanical Power
• Postoperative Pulmonary Complications
• Protective Ventilation

Intervention

Other:
• periodic alveolar recruitment maneuvers
A stepwise increment of tidal volume was used for each ARM.
• positive end-expiratory pressure
a PEEP of 6 to 8 cm H2O

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mechanical power during capnoperitoneum	mechanical power, J/min	30 minutes after starting carbon dioxide pneumoperitoneum
Secondary	Accumulative mechanical power (AMP)	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	During intraoperative mechanical ventilation, an average of 3 hours
Secondary	An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)	P/F ratio, mmHg	Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Secondary	Shunt fraction	Shunt fraction, %	Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Secondary	Dead space rate	Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.	Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
Secondary	Rate of respiratory failure at post-anesthesia care unit (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.	Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU
Secondary	Soluble advanced glycation end products receptor (sRAGE)	The concentration of plasma sRAGE, pg/ml	20 minutes after entering PACU
Secondary	Clara cell protein 16 (CC16)	The concentration of plasma CC16, ng/ml	20 minutes after entering PACU
Secondary	Surfactant Protein D (SP-D)	The concentration of plasma SP-D, ug/ml	20 minutes after entering PACU
Secondary	Interleukin 6 (IL-6)	The concentration of plasma IL-6, pg/ml	20 minutes after entering PACU
Secondary	Rate of postoperative respiratory failure	Respiratory failure: PaO2 < 60 mmHg or SpO2 < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.	Time Frame: Day 0 to 3 after surgery
Secondary	Rate of sustained hypoxaemia	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 (?SpO2, preoperative SpO2 minus postoperative SpO2) = 5%.	Day 0 to 3 after surgery
Secondary	Postoperative pulmonary complications score	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).	Day 0 to 3 after surgery
Secondary	Postoperative hospitalization days	The duration between the operation date and the actual discharge date.	Day 0 to 30 after surgery
Secondary	Death from any cause	Intraoperative or postoperative death from any cause	Day 0 to 30 after surgery
Secondary	Rate of intraoperative hypotension	Intraoperative hypotension, mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes.	During intraoperative mechanical ventilation, an average of 3 hours
Secondary	Rate of need for vasoconstrictors	MAP < 60 mmHg and using any vasoconstrictors.	During intraoperative mechanical ventilation, an average of 3 hours
Secondary	Rate of intraoperative hypoxemia	Intraoperative hypoxemia, SpO2 = 92% lasting more than 3 minutes.	During intraoperative mechanical ventilation, an average of 3 hours
Secondary	Rate of intraoperative bradycardia	Intraoperative bradycardia, heart rate = 50 bpm and the decrease of heart rate from the basic value = 20% lasting more than 3 minutes.	During intraoperative mechanical ventilation, an average of 3 hours
Secondary	Rate of pneumothorax	Pneumothorax, air in the pleural space with no vascular bed surrounding the visceral pleura.	During surgery or within 7 days after surgery
Secondary	Rate of pleural effusion	Pleural effusion, diagnosed according to previous literature (Doi: 10.1097/EJA.0000000000000118).	within 7 days after surgery
Secondary	Unexpected admission to ICU	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.	within 30 days after surgery
Secondary	Tumor Necrosis Factor alpha (TNF-a)	TNF-a, pg/ml.	20 minutes after entering PACU