Effect of Placing the Endotracheal Tube Beyond Cervical C7 Level in Anterior Cervical Decompression and Fusion Surgery

NCT06473077 | Not Yet Recruiting

• 1 other identifier: JEP-2024-054
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Endotracheal intubation is performed to secure the patient's airway during general anaesthesia undergoing surgery. The procedure involves placing a tube known as endotracheal tube (ETT) mouth into the trachea. The ETT usually has a cuff at the distal part of the tube which functions as a seal to the trachea for proper delivery serves as protection against the ingress of pathogens and fluids from the pharyngeal space into the lower airways. During intubation, the cuff usually positioned just beyond the vocal cord which is anatomically situated at cervical vertebrae C5 to C6 in adult. After intubation, the endotracheal cuff pressure (ETCP) is checked once or intermittently and kept within appropriate range as cuff overinflation can cause complications that range from mild sore throat to tracheal ischemia, tracheal rupture and fistula formation. The recommended range for ETCP is between 20 to 30 cm H2O. For surgeries performed on head and neck region, the monitoring of ETCP is difficult as this might intrude into the sterile surgical field. Anterior decompression and fusion (ACDF) surgery is commonly performed to treat cervical spine issues such as herniated discs, spinal stenosis, or degenerative disc disease. During ACDF, the surgeon accesses the cervical spine from the anterior of the neck by moving aside the soft tissues to gain access to the spine. While doing this, a surgical retractor is often used to hold the tissues aside carotid sheath laterally, and the trachea and the oesophagus medially. Placement of a retractor during ACDF may inadvertently lead to compression or pressure on the conventionaly placed ETT resulted in rise in ETCP as high as 50 mmHg and causes airway complications such as dysphagia, sore throat and dysphonia. We hypothesize by positioning the endotracheal cuff deeper beyond the cervical vertebrae C7 would not cause significant rise in ETCP during retractor placement based on the assumption that the surgical retractor would not directly compress on the cuff. The investigators designed this study to observe ETCP changes before and after retractor placement and associated complication.

Conditions

Anterior Spinal Artery Compression Syndromes, Cervical Region

Keywords

ENDOTRACHEAL CUFF PRESSURE CHANGES; ANTERIOR CERVICAL DECOMPRESSION AND FUSION SURGERY; CONTINUOUS ENDOTRACHEAL CUFF PRESSURE MONITOR

Outcome Measures

Primary Outcomes (1)

• Measurement of the ETCP of patients before and after surgical retractor placement during ACDF surgeries.

  Monitoring of ETCP variation every 15 minutes

  Through out the duration of the surgery

Secondary Outcomes (1)

• Assessment of sore throat, dysphagia, and hoarseness of voice after extubation

  At completion of the surgery, up to 24 hours

Study Arms (1)

ACDF Patients

Single Group of patients planned for anterior cervical decompression and fusion

Procedure: ETT beyond C7 level

Interventions

ETT beyond C7 level PROCEDURE

Endotracheal cuff is placed deeper beyond C7 level, but above carina

ACDF Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled to undergo ACDF surgery, aged between 18 years and 80 years and under American Society of Anaesthesiologists (ASA) classification of I,II or III will be included. All patients recruited will undergo pre-operative assessment as per our local institution protocol. Explanation of the study and written informed consent will be taken during this assessment. Exclusion criteria will include patients who is already ventilated prior to ACDF surgery, anatomical deformity in the neck and patients with existing sore throat, dysphagia and hoarseness of voice.

You may qualify if:

• ACDF surgery
• Age between 18-80 years
• ASA I, II or III

You may not qualify if:

• Patients who is already ventilated prior to ACDF surgery
• Anatomical deformity in the neck
• Pre-existing sore throat, dysphagia, hoarseness of voice

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

University Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

Location

Study Officials

• Chian Yong Liu, MD

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chian Yong Liu, MD

CONTACT

0391455783; chianyong@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Senior Lecturer,

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: June 25, 2024
• Study Start: June 24, 2024
• Primary Completion: January 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

MY (1)