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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversiti Kebangsaan Malaysia Medical Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ACDF surgery

Age between 18-80 years

ASA I, II or III

Disqualifiers

Patients who is already ventilated prior to ACDF surgery

Anatomical deformity in the neck

Pre-existing sore throat, dysphagia, hoarseness of voice

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ETT beyond C7 level

    Procedure/Surgery

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

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: ACDF Patients1 intervention

Trial outcomes

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

Time frame
Through out the duration of the surgery

Secondary outcomes

1

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

Using scoring system that previously established in clinical studies

Time frame
At completion of the surgery, up to 24 hours

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University Kebangsaan Malaysia Status unavailable 56000, Bandar Tun Razak, Kuala LumpurMalaysiaMalaysia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: